{"title":"Clinical trials Books","description":"","products":[{"product_id":"the-trial-a-dark-and-gripping-twisty-thriller-for-2024-9780008520120","title":"The Trial A dark and gripping twisty thriller for","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003ePacy, dark and highly entertaining, with a real sense of menace' Sunday Times bestseller, T.M. LoganThe very definition of a white-knuckle ride' Sunday Times bestseller, B P WalterBrilliant . . . a proper page-turner' Sunday Times bestseller, Laura MarshallWould you sign up to a medical trial if you didn't know the possible side effects?18-40? PAID CLINICAL TRIAL IN THE CANARY ISLANDS  UP TO 20,000 TAX FREE It seems like the opportunity of a lifetime. An all-inclusive luxury trip abroad, all you need to do is take a pill every day and keep a diary.Except you don't know anything about the drug or what its side effects might be.The headaches start, a dull ache at first. Every day worse than the last.Then a body is found.Everyone is a suspect. Anyone could be a killer. Even you . . .The up-all-night thriller perfect for fans of Alex Michaelides, T. M. Logan and JP DelaneyEarly readers have signed up for The Trial . . . will you?Such a cool premise . . . a page-turner that kept me gripped'\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e‘Intelligent and \u003cstrong\u003ethought-provoking\u003c\/strong\u003e’ Victoria Selman\u003c\/p\u003e           \u003cp\u003e‘Smart, fast and scary. For any reader, it’s an \u003cstrong\u003eunforgettable\u003c\/strong\u003e trip’ Rachel Edwards\u003c\/p\u003e           \u003cp\u003e‘An \u003cstrong\u003eintense\u003c\/strong\u003e mystery which moves and twists and left me always off-balance. Full of \u003cstrong\u003eforeboding and vivid\u003c\/strong\u003e characters’ James Delargy\u003c\/p\u003e","brand":"HarperCollins Publishers","offers":[{"title":"Default Title","offer_id":48864003785047,"sku":"9780008520120","price":8.54,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780008520120.jpg?v=1722269956"},{"product_id":"clinical-trials-9781394195664","title":"Clinical Trials","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eComprehensive resource presenting methods essential in planning, designing, conducting, analyzing, and interpreting clinical trials The Fourth Edition of Clinical Trials builds on the text's reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials, discussing principles of design for various types of clinical trials and elements of planning the experiment, assembling a study cohort, assessing data, and reporting results.  Each chapter contains an introduction and summary to reinforce key points. Discussion questions stimulate critical thinking and help readers understand how they can apply their newfound knowledge. Written by a highly qualified author with significant experience in the field, the Fourth Edition of Clinical Trials approaches the topic with: Problems that may arise during a trial, and accompanying common sense solutionsDesign alternatives for addressing many questions in therapeutic developmentStatistical principles with new and provocative topics, such as generalizing results, operating characteristics, trial issues during the COVID-19 pandemic, and moreAlternative medicine, ethics, middle development, comparative studies, adaptive designs, and clinical trials using point of care dataRevamped exercise sets, updated and extensive references, new material on endpoints and the developmental pipeline, and revisions of numerous sections, tables, and figures Standing out due to its accessible and broad coverage of statistical design methods which are the building blocks of clinical trials and medical research, Clinical Trials is an essential learning aid on the subject for undergraduate and graduate clinical trials courses.","brand":"Wiley-Blackwell","offers":[{"title":"Default Title","offer_id":48885459517783,"sku":"9781394195664","price":120.6,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781394195664.jpg?v=1722536489"},{"product_id":"economic-evaluation-of-cancer-drugs-9781498761307","title":"Economic Evaluation of Cancer Drugs","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eCancer is a major healthcare burden across the world and impacts not only the people diagnosed with various cancers but also their families, carers, and healthcare systems. With advances in the diagnosis and treatment, more people are diagnosed early and receive treatments for a disease where few treatments options were previously available. As a result, the survival of patients with cancer has steadily improved and, in most cases, patients who are not cured may receive multiple lines of treatment, often with financial consequences for the patients, insurers and healthcare systems. Although many books exist that address economic evaluation, \u003cb\u003eEconomic Evaluation of Cancer Drugs using Clinical Trial and Real World Data\u003c\/b\u003e is the first unified text that specifically addresses the economic evaluation of cancer drugs. \u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThe authors discuss how to perform cost-effectiveness analyses while emphasising the strategic importance of designing cost-effectiveness into cancer trial\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\u003cem\u003e\"\u003c\/em\u003eThis book is highly recommended for readers searching for an introductory text to the world of health economic analysis. The authors provide timely examples from both clinical trials in oncology and subsequent real-world application, discussing implications of findings and how they could potentially be applied to make future trials and real-world applications more efficient. \u003cem\u003e~Nuru Noor, ISCB News\u003c\/em\u003e\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eContents\u003c\/p\u003e\u003cp\u003ePreface......................................................................................................................xv\u003c\/p\u003e\u003cp\u003eAcknowledgments.............................................................................................. xvii\u003c\/p\u003e\u003cp\u003eAcronyms and Abbreviations............................................................................ xix\u003c\/p\u003e\u003cp\u003e1 Introduction to Cancer....................................................................................1\u003c\/p\u003e\u003cp\u003e1.1 Cancer......................................................................................................1\u003c\/p\u003e\u003cp\u003e1.2 Epidemiology of Cancer........................................................................1\u003c\/p\u003e\u003cp\u003e1.2.1 Cancer Trends............................................................................2\u003c\/p\u003e\u003cp\u003e1.3 Prognostic Factors Associated with Cancer Outcomes ...................5\u003c\/p\u003e\u003cp\u003e1.4 Economic Burden of Cancer.................................................................6\u003c\/p\u003e\u003cp\u003e1.4.1 Health Expenditure..................................................................6\u003c\/p\u003e\u003cp\u003e1.4.2 Healthcare Expenditure on Drugs.........................................7\u003c\/p\u003e\u003cp\u003e1.5 Treatments for Cancer......................................................................... 10\u003c\/p\u003e\u003cp\u003e1.6 Important Economic Concepts for Cost-Effectiveness of\u003c\/p\u003e\u003cp\u003eCancer Interventions......................................................... 12\u003c\/p\u003e\u003cp\u003e1.6.1 Economics, Health Economics, Economic Evaluation,\u003c\/p\u003e\u003cp\u003eand Pharmacoeconomics .................................................. 12\u003c\/p\u003e\u003cp\u003e1.6.1.1 Value ......................................................................... 13\u003c\/p\u003e\u003cp\u003e1.6.1.2 Allocative Efficiency............................................... 14\u003c\/p\u003e\u003cp\u003e1.6.1.3 Technical Efficiency................................................ 15\u003c\/p\u003e\u003cp\u003e1.6.1.4 Opportunity Cost.................................................... 16\u003c\/p\u003e\u003cp\u003e1.6.1.5 Discounting.............................................................. 17\u003c\/p\u003e\u003cp\u003e1.6.1.6 The Incremental Cost-Effectiveness Ratio .......... 18\u003c\/p\u003e\u003cp\u003e1.6.1.7 The Cost-Effectiveness Plane................................. 19\u003c\/p\u003e\u003cp\u003e1.6.1.8 Quality-Adjusted Life-Years (QALY) ...................22\u003c\/p\u003e\u003cp\u003e1.7 Health Economic Evaluation and Cancer Drug\u003c\/p\u003e\u003cp\u003eDevelopment in Practice .........................................................................23\u003c\/p\u003e\u003cp\u003e1.7.1 The Modern Paradigm................................................................... 24\u003c\/p\u003e\u003cp\u003e1.8 Efficacy versus Effectiveness .............................................................26\u003c\/p\u003e\u003cp\u003e1.9 Real-World Data ..................................................................................27\u003c\/p\u003e\u003cp\u003e1.10 Economic versus Clinical Hypotheses .............................................29\u003c\/p\u003e\u003cp\u003e1.11 Summary............................................................................................... 32\u003c\/p\u003e\u003cp\u003e1.12 Exercises for Chapter 1........................................................................33\u003c\/p\u003e\u003cp\u003e2 Important Outcomes for Economic Evaluation in Cancer Studies......35\u003c\/p\u003e\u003cp\u003e2.1 Introduction .........................................................................................35\u003c\/p\u003e\u003cp\u003e2.2 Important Common, Surrogate, and Novel Cancer Endpoints............... 36\u003c\/p\u003e\u003cp\u003e2.2.1 Overall Survival......................................................................36\u003c\/p\u003e\u003cp\u003e2.2.1.1 OS and Economic Evaluation ............................... 41\u003c\/p\u003e\u003cp\u003e2.2.2 Surrogate Endpoints...............................................................46\u003c\/p\u003e\u003cp\u003e2.3 HTAs with Surrogate Endpoints.......................................................53\u003c\/p\u003e\u003cp\u003e2.4 Emerging Tumor-Centered Endpoints.............................................55\u003c\/p\u003e\u003cp\u003e2.5 Demonstrating Value from Other Cancer Endpoints..................... 57\u003c\/p\u003e\u003cp\u003e2.6 Summary...............................................................................................58\u003c\/p\u003e\u003cp\u003e2.7 Exercises for Chapter 2........................................................................58\u003c\/p\u003e\u003cp\u003e3 Health-Related Quality of Life for Cost-Effectiveness.......................... 59\u003c\/p\u003e\u003cp\u003e3.1 Health-Related Quality of Life (HRQoL) in Cancer Patients......... 59\u003c\/p\u003e\u003cp\u003e3.1.1 Limitations of Anti-Cancer Treatments...............................59\u003c\/p\u003e\u003cp\u003e3.1.2 Why Collect HRQoL Data?....................................................60\u003c\/p\u003e\u003cp\u003e3.1.3 Challenges with HRQoL in Cancer Studies........................ 61\u003c\/p\u003e\u003cp\u003e3.2 Measuring Health-Related Quality of Life Outcomes for\u003c\/p\u003e\u003cp\u003eCommon Cancer Types .................................................................62\u003c\/p\u003e\u003cp\u003e3.2.1 Condition-Specific Measures of HRQoL ............................ 62\u003c\/p\u003e\u003cp\u003e3.2.2 Common General Condition-Specific Measures of\u003c\/p\u003e\u003cp\u003eHRQoL in Cancer......................................................................................63\u003c\/p\u003e\u003cp\u003e3.3 Measuring HRQoL for Economic Evaluation ................................. 67\u003c\/p\u003e\u003cp\u003e3.3.1 EuroQol EQ-5D-3L and 5L....................................................68\u003c\/p\u003e\u003cp\u003e3.3.2 EuroQol EQ-5D-5L................................................................. 69\u003c\/p\u003e\u003cp\u003e3.4 Constructing Utilities.......................................................................... 70\u003c\/p\u003e\u003cp\u003e3.5 Quality-Adjusted Life-Years (QALYs)................................................72\u003c\/p\u003e\u003cp\u003e3.5.1 QALY Calculation in Cancer Trials......................................73\u003c\/p\u003e\u003cp\u003e3.6 Economic Evaluation in the Absence of Utility Data:\u003c\/p\u003e\u003cp\u003eMapping and Utility Studies ................................................................. 74\u003c\/p\u003e\u003cp\u003e3.7 Sensitivity and Responsiveness of EQ-5D versus QLQ-C30\u003c\/p\u003e\u003cp\u003eHRQoL for Detecting Improvement in Cancer Patients ...................... 76\u003c\/p\u003e\u003cp\u003e3.8 Measuring Post-Progression (PP) Utility: Some Approaches .......77\u003c\/p\u003e\u003cp\u003eWhy Is Estimation of Utility between Disease Progression\u003c\/p\u003e\u003cp\u003eand Death Relevant?............................................................... 78\u003c\/p\u003e\u003cp\u003eThe Behavior of Utility in Cancer Patients between\u003c\/p\u003e\u003cp\u003eProgression and Death?.........................................................79\u003c\/p\u003e\u003cp\u003e3.8.1 Plausible Post-Progression Utility Behavior ......................80\u003c\/p\u003e\u003cp\u003e3.8.2 Non-Linear Models.................................................................82\u003c\/p\u003e\u003cp\u003e3.9 HRQoL issues in Health Technology Appraisals of Cancer\u003c\/p\u003e\u003cp\u003eDrugs .........................................................................................................87\u003c\/p\u003e\u003cp\u003e3.10 Summary...............................................................................................89\u003c\/p\u003e\u003cp\u003e3.11 Exercises for Chapter 3........................................................................89\u003c\/p\u003e\u003cp\u003e4 Introductory Statistical Methods for Economic Evaluation in\u003c\/p\u003e\u003cp\u003eCancer............................................................................................................... 91\u003c\/p\u003e\u003cp\u003e4.1 Introduction.......................................................................................... 91\u003c\/p\u003e\u003cp\u003e4.2 Uncertainty and Variability................................................................ 91\u003c\/p\u003e\u003cp\u003e4.2.1 Uncertainty..............................................................................92\u003c\/p\u003e\u003cp\u003e4.2.2 Variability.................................................................................92\u003c\/p\u003e\u003cp\u003e4.2.2.1 Hypothesis Testing.................................................93\u003c\/p\u003e\u003cp\u003e4.3 Distributions: Cost, Utility, and Survival Data ...............................93\u003c\/p\u003e\u003cp\u003e4.4 Important Measures Used in Cancer Trials.....................................95\u003c\/p\u003e\u003cp\u003e4.4.1 Time-to-Event Endpoints.......................................................95\u003c\/p\u003e\u003cp\u003e4.4.2 Median Survival.....................................................................96\u003c\/p\u003e\u003cp\u003e4.4.3 Hazard Rate and Hazard Ratio............................................98\u003c\/p\u003e\u003cp\u003e4.4.4 Hazard Ratio............................................................................99\u003c\/p\u003e\u003cp\u003e4.4.5 Survival Rates and Proportions.......................................... 101\u003c\/p\u003e\u003cp\u003e4.4.6 Relationship between Hazard Rate and Survival Rate......102\u003c\/p\u003e\u003cp\u003e4.4.7 Transition Probability and Matrix...................................... 103\u003c\/p\u003e\u003cp\u003e4.4.8 Relation between Transition Probability and\u003c\/p\u003e\u003cp\u003eSurvival Rates .............................................................................. 104\u003c\/p\u003e\u003cp\u003e4.4.9 Proportional Hazards.......................................................... 106\u003c\/p\u003e\u003cp\u003e4.4.10 Mean Survival and Restricted Mean ................................ 106\u003c\/p\u003e\u003cp\u003e4.5 Simulation: Bootstrapping and Monte-Carlo Simulation............ 109\u003c\/p\u003e\u003cp\u003e4.5.1 Simulating Using Monte-Carlo Sampling......................... 111\u003c\/p\u003e\u003cp\u003e4.6 Analyzing Data from Cancer Trials................................................ 111\u003c\/p\u003e\u003cp\u003e4.6.1 Semi-Parametric Methods: The Cox PH Model............... 111\u003c\/p\u003e\u003cp\u003e4.6.1.1 Adjusting for Covariates with the Cox Model......112\u003c\/p\u003e\u003cp\u003e4.6.1.2 Using Hazard Ratios to Predict Survival Rates.....113\u003c\/p\u003e\u003cp\u003e4.6.2 Parametric Methods: Modeling Survival Data for\u003c\/p\u003e\u003cp\u003eExtrapolation ........................................................................... 114\u003c\/p\u003e\u003cp\u003e4.6.3 Advanced Modeling Techniques for Survival Data ....... 118\u003c\/p\u003e\u003cp\u003e4.6.3.1 Flexible Parametric Survival Models................. 118\u003c\/p\u003e\u003cp\u003e4.6.3.2 Applications in Cancer Surveillance ................. 119\u003c\/p\u003e\u003cp\u003e4.7 Issues in Fitting Models....................................................................122\u003c\/p\u003e\u003cp\u003e4.8 Handling Crossover, Treatment Switching, and\u003c\/p\u003e\u003cp\u003eSubsequent Anti-Cancer Therapy ............................................. 123\u003c\/p\u003e\u003cp\u003e4.8.1 Introduction to Treatment Switching................................. 123\u003c\/p\u003e\u003cp\u003e4.8.2 Types of Switching ............................................................... 124\u003c\/p\u003e\u003cp\u003e4.8.3 Implications of Switching.................................................... 124\u003c\/p\u003e\u003cp\u003e4.8.4 Handling Switching in Statistical Analyses .................... 126\u003c\/p\u003e\u003cp\u003e4.8.4.1 Intent-to-Treat (ITT)............................................... 127\u003c\/p\u003e\u003cp\u003e4.8.4.2 Per Protocol Analysis............................................ 128\u003c\/p\u003e\u003cp\u003e4.8.4.3 IPCW....................................................................... 128\u003c\/p\u003e\u003cp\u003e4.8.4.4 RPFSTM.................................................................. 129\u003c\/p\u003e\u003cp\u003e4.8.4.5 Two-Stage Adjustment Model ............................ 131\u003c\/p\u003e\u003cp\u003e4.8.4.6 Other Approaches: Structural\u003c\/p\u003e\u003cp\u003eNested Mean Models (SNNM) ............................................................. 131\u003c\/p\u003e\u003cp\u003e4.9 Data Synthesis and Network Meta-Analyses................................ 132\u003c\/p\u003e\u003cp\u003e4.9.1 Mixed Treatment Comparisons ......................................... 132\u003c\/p\u003e\u003cp\u003e4.9.1.1 Direct Comparison................................................ 133\u003c\/p\u003e\u003cp\u003e4.9.1.2 Indirect Treatment Comparison (ITC) .............. 133\u003c\/p\u003e\u003cp\u003e4.9.1.3 Meta-Analysis ....................................................... 134\u003c\/p\u003e\u003cp\u003e4.9.1.4 Network of Evidence ........................................... 134\u003c\/p\u003e\u003cp\u003e4.9.2 Assumptions for Carrying Out MTCs .............................. 134\u003c\/p\u003e\u003cp\u003e4.10 Summary............................................................................................. 138\u003c\/p\u003e\u003cp\u003e4.11 Exercises for Chapter 4...................................................................... 140\u003c\/p\u003e\u003cp\u003e5 Collecting and Analysis of Costs from Cancer Studies...................... 141\u003c\/p\u003e\u003cp\u003e5.1 Types of Costs Typical of Cancer Trials.......................................... 141\u003c\/p\u003e\u003cp\u003e5.1.1 Categorization of Health Resource Use............................. 142\u003c\/p\u003e\u003cp\u003e5.1.2 Resource Use Monitoring.................................................... 142\u003c\/p\u003e\u003cp\u003e5.1.3 Baseline Characteristics and Health Resource Use......... 143\u003c\/p\u003e\u003cp\u003e5.1.4 Costs Determined by a Study Protocol.............................. 144\u003c\/p\u003e\u003cp\u003e5.2 Perspective of Analysis and Costs Collection................................ 145\u003c\/p\u003e\u003cp\u003e5.3 Collecting Health Resource Use across the Treatment\u003c\/p\u003e\u003cp\u003ePathway ....................................................................................... 146\u003c\/p\u003e\u003cp\u003e5.3.1 Time Horizon ....................................................................... 148\u003c\/p\u003e\u003cp\u003e5.4 Costing Methods: Micro versus Macro Approach........................ 150\u003c\/p\u003e\u003cp\u003e5.4.1 Average versus Marginal and Incremental Cost.............. 151\u003c\/p\u003e\u003cp\u003e5.4.2 Inflation.................................................................................. 152\u003c\/p\u003e\u003cp\u003e5.4.3 Time Preference and Discounting...................................... 153\u003c\/p\u003e\u003cp\u003e5.5 Charges................................................................................................ 154\u003c\/p\u003e\u003cp\u003e5.5.1 Cost-to-Charge Ratios.......................................................... 155\u003c\/p\u003e\u003cp\u003e5.5.2 Other Non-Medical Costs (e.g. Societal Costs)................. 155\u003c\/p\u003e\u003cp\u003e5.6 Distribution of Costs.......................................................................... 155\u003c\/p\u003e\u003cp\u003e5.6.1 Transforming Cost Data....................................................... 157\u003c\/p\u003e\u003cp\u003e5.7 Handling Censored and Missing Costs ........................................ 158\u003c\/p\u003e\u003cp\u003e5.7.1 Strategies for Avoiding Missing Resource Data .............. 160\u003c\/p\u003e\u003cp\u003e5.7.2 Strategies for Analyzing Cost Data\u003c\/p\u003e\u003cp\u003eWhen Data Are Missing or Censored ..................................... 160\u003c\/p\u003e\u003cp\u003e5.7.3 Imputation Methods............................................................. 161\u003c\/p\u003e\u003cp\u003e5.8 Handling Future Costs...................................................................... 162\u003c\/p\u003e\u003cp\u003e5.9 Case Report Forms and Health Resource Use............................... 164\u003c\/p\u003e\u003cp\u003e5.10 Statistical Analyses of Costs ............................................................ 165\u003c\/p\u003e\u003cp\u003e5.11 Summary............................................................................................. 172\u003c\/p\u003e\u003cp\u003e5.12 Exercises for Chapter 5...................................................................... 173\u003c\/p\u003e\u003cp\u003e6 Designing Cost-Effectiveness into Cancer Trials................................. 175\u003c\/p\u003e\u003cp\u003e6.1 Introduction and Reasons for Collecting Economic\u003c\/p\u003e\u003cp\u003eData in a Clinical Trial ........................................................................... 175\u003c\/p\u003e\u003cp\u003e6.2 Clinical Trial Designs for Cancer Studies...................................... 178\u003c\/p\u003e\u003cp\u003e6.2.1 Clinical Trial Designs........................................................... 178\u003c\/p\u003e\u003cp\u003e6.2.2 Interim Analyses and Data Monitoring Committees\u003c\/p\u003e\u003cp\u003e(DMC)..................................................................................... 188\u003c\/p\u003e\u003cp\u003e6.3 Planning a Health Economic Evaluation in a Clinical Trial ....... 191\u003c\/p\u003e\u003cp\u003e6.3.1 Important Considerations When Designing\u003c\/p\u003e\u003cp\u003ea Cancer Study for Economic Evaluation ............................................... 191\u003c\/p\u003e\u003cp\u003e6.3.2 Integrating Economic Evaluation in a Clinical Trial:\u003c\/p\u003e\u003cp\u003eConsiderations .......................................................................... 194\u003c\/p\u003e\u003cp\u003e6.3.3 Endpoints and Outcomes.................................................... 196\u003c\/p\u003e\u003cp\u003e6.3.3.1 Timing of Measurements..................................... 198\u003c\/p\u003e\u003cp\u003e6.3.3.2 Trial Design............................................................ 198\u003c\/p\u003e\u003cp\u003e6.3.3.3 CRF Design............................................................ 199\u003c\/p\u003e\u003cp\u003e6.3.3.4 Sample Size Methods for Cost-Effectiveness....... 199\u003c\/p\u003e\u003cp\u003e6.3.3.5 Sample Size Formulae for\u003c\/p\u003e\u003cp\u003eCost-Effectiveness: Examples .................................................... 201\u003c\/p\u003e\u003cp\u003e6.3.4 Treatment Pathways.............................................................204\u003c\/p\u003e\u003cp\u003e6.3.5 Time of Generic\/Competition Entry..................................204\u003c\/p\u003e\u003cp\u003e6.3.6 Treatment Compliance.........................................................205\u003c\/p\u003e\u003cp\u003e6.3.7 Identify Subgroups\/Heterogeneity....................................206\u003c\/p\u003e\u003cp\u003e6.3.8 Early ICER\/INMB.................................................................206\u003c\/p\u003e\u003cp\u003e6.3.9 Multicenter Trials.................................................................. 207\u003c\/p\u003e\u003cp\u003e6.4 Case Study of Economic Evaluation of Cancer Trials................... 210\u003c\/p\u003e\u003cp\u003e6.4.1 TA516 Cabozanitib + Vandetanib....................................... 210\u003c\/p\u003e\u003cp\u003e6.5 Summary............................................................................................. 210\u003c\/p\u003e\u003cp\u003e6.6 Exercises for Chapter 6...................................................................... 213\u003c\/p\u003e\u003cp\u003e7 Models for Economic Evaluation of Cancer........................................... 215\u003c\/p\u003e\u003cp\u003e7.1 Types of Health Economic Models.................................................. 215\u003c\/p\u003e\u003cp\u003e7.2 Decision Tree Models........................................................................ 215\u003c\/p\u003e\u003cp\u003e7.2.1 Further Possible Improvements to the\u003c\/p\u003e\u003cp\u003eDecision Model ......................................................................................224\u003c\/p\u003e\u003cp\u003e7.3 Markov Models..................................................................................226\u003c\/p\u003e\u003cp\u003e7.4 Continuous Time Markov Models...................................................230\u003c\/p\u003e\u003cp\u003e7.5 The Partitioned Survival Model...................................................... 231\u003c\/p\u003e\u003cp\u003e7.5.1 Developing an Economic Model Using Patient-Level\u003c\/p\u003e\u003cp\u003eData Using a Partitioned Survival Model Approach ......................... 231\u003c\/p\u003e\u003cp\u003e7.5.1.1 Modeling the Efficacy Data (Survival Data)............................ 231\u003c\/p\u003e\u003cp\u003e7.5.2 Case Study of an Economic Model Using Patient-\u003c\/p\u003e\u003cp\u003eLevel Data: A Partitioned Survival Model..................................................... 232\u003c\/p\u003e\u003cp\u003e7.5.3 Crossover...............................................................................236\u003c\/p\u003e\u003cp\u003e7.6 Summary of Cost-Effectiveness Models for Cancer\u003c\/p\u003e\u003cp\u003eUsed in HTA Submissions ....................................................................239\u003c\/p\u003e\u003cp\u003e7.7 Summary............................................................................................. 243\u003c\/p\u003e\u003cp\u003e7.8 Exercises for Chapter 7...................................................................... 243\u003c\/p\u003e\u003cp\u003e8 Real-World Data in Cost-Effectiveness\u003c\/p\u003e\u003cp\u003eStudies on Cancer ....................................................................................... 249\u003c\/p\u003e\u003cp\u003e8.1 Introduction to Real-World Data..................................................... 249\u003c\/p\u003e\u003cp\u003e8.2 Using RWD to Support Cost-Effectiveness Analysis ................... 251\u003c\/p\u003e\u003cp\u003e8.3 Strengths and Limitations of Using RWD to Support\u003c\/p\u003e\u003cp\u003eCost-Effectiveness Analysis .....................................................253\u003c\/p\u003e\u003cp\u003e8.3.1 Limitations.............................................................................255\u003c\/p\u003e\u003cp\u003e8.3.2 Internal Validity versus Generalizability..........................256\u003c\/p\u003e\u003cp\u003e8.4 Sources for RWD Generation........................................................... 257\u003c\/p\u003e\u003cp\u003e8.4.1 Registries ...............................................................................260\u003c\/p\u003e\u003cp\u003e8.4.2 Audits .................................................................................... 261\u003c\/p\u003e\u003cp\u003e8.4.3 Primary Care Databases: CPRD, THIN, QResearch........ 262\u003c\/p\u003e\u003cp\u003e8.4.4 Insurance Claims Databases...............................................263\u003c\/p\u003e\u003cp\u003e8.4.5 Digital Data Sources, Social Media and Applications....... 263\u003c\/p\u003e\u003cp\u003e8.4.6 Commercial Data Sources...................................................264\u003c\/p\u003e\u003cp\u003e8.4.7 Pragmatic Clinical Trials.....................................................264\u003c\/p\u003e\u003cp\u003e8.4.8 Prospective Observational Research Studies...................265\u003c\/p\u003e\u003cp\u003e8.4.9 Case Control Studies............................................................265\u003c\/p\u003e\u003cp\u003e8.5 Using Cancer Registries....................................................................265\u003c\/p\u003e\u003cp\u003e8.5.1 Examples of Registries in the UK for RWE ...................... 267\u003c\/p\u003e\u003cp\u003e8.6 Statistical Analyses of RWD: Addressing Selection Bias.............268\u003c\/p\u003e\u003cp\u003e8.6.1 Propensity Score Modeling.................................................268\u003c\/p\u003e\u003cp\u003e8.6.2 Instrumental Variable Methods.......................................... 274\u003c\/p\u003e\u003cp\u003eResults..................................................................................................277\u003c\/p\u003e\u003cp\u003e8.7 Summary and Conclusion................................................................ 279\u003c\/p\u003e\u003cp\u003e8.8 Exercises for Chapter 8...................................................................... 281\u003c\/p\u003e\u003cp\u003e9 Reporting and Interpreting Results of Cost-Effectiveness\u003c\/p\u003e\u003cp\u003eAnalyses from Cancer Trials.....................................................................283\u003c\/p\u003e\u003cp\u003e9.1 Interpreting Incremental Costs and QALYs...................................283\u003c\/p\u003e\u003cp\u003e9.1.1 Informative Censoring.........................................................284\u003c\/p\u003e\u003cp\u003e9.2 Interpreting Incremental QALYs..................................................... 287\u003c\/p\u003e\u003cp\u003e9.3 Relationship between Costs and QALYs........................................290\u003c\/p\u003e\u003cp\u003e9.4 Interpreting the ICER and the Cost-Effectiveness Plane.............. 292\u003c\/p\u003e\u003cp\u003e9.4.1 Uncertainty............................................................................ 292\u003c\/p\u003e\u003cp\u003e9.5 Presenting and Interpreting Results from Uncertainty\u003c\/p\u003e\u003cp\u003eAnalysis ....................................................................................................296\u003c\/p\u003e\u003cp\u003e9.6 Bayesian Sensitivity Analysis...........................................................306\u003c\/p\u003e\u003cp\u003e9.6.1 Limitations of the ICER and Using the INMB..................307\u003c\/p\u003e\u003cp\u003e9.7 Presenting and Interpreting Results from Value of\u003c\/p\u003e\u003cp\u003eInformation Analyses .............................................................................308\u003c\/p\u003e\u003cp\u003e9.8 Challenges of VOI Analysis in Healthcare Decisions................... 316\u003c\/p\u003e\u003cp\u003e9.9 Summary ............................................................................................ 317\u003c\/p\u003e\u003cp\u003e9.10 Exercises for Chapter 9...................................................................... 317\u003c\/p\u003e\u003cp\u003eTechnical Appendix for Chapter 9.............................................................. 318\u003c\/p\u003e\u003cp\u003eA9.1 Simulation.............................................................................. 318\u003c\/p\u003e\u003cp\u003eA9.2 Bayesian PSA......................................................................... 319\u003c\/p\u003e\u003cp\u003eA9.3 Value of Information............................................................ 320\u003c\/p\u003e\u003cp\u003eBefore Any Data Is Observed........................................................... 321\u003c\/p\u003e\u003cp\u003eAfter Data Have Been Observed...................................................... 321\u003c\/p\u003e\u003cp\u003e10 Factors Predictive of HTA Success and the Global Landscape.......... 323\u003c\/p\u003e\u003cp\u003e10.1 Introduction........................................................................................ 323\u003c\/p\u003e\u003cp\u003e10.2 Cancer Drugs Rejected by NICE...................................................... 323\u003c\/p\u003e\u003cp\u003e10.3 Summary of Criticisms of Economic Models of Cancer.............. 324\u003c\/p\u003e\u003cp\u003e10.4 Factors Predictive of Successful HTAs in Cancer..........................335\u003c\/p\u003e\u003cp\u003e10.5 The Changing Pace of the Reimbursement Environment .......... 341\u003c\/p\u003e\u003cp\u003e10.6 Reimbursement and Payer Evidence Requirements\u003c\/p\u003e\u003cp\u003eAcross Different Countries ...........................................................344\u003c\/p\u003e\u003cp\u003e10.6.1 Canada....................................................................................345\u003c\/p\u003e\u003cp\u003e10.6.2 France......................................................................................345\u003c\/p\u003e\u003cp\u003e10.6.3 Germany.................................................................................346\u003c\/p\u003e\u003cp\u003e10.6.4 Italy.........................................................................................347\u003c\/p\u003e\u003cp\u003e10.6.5 Spain.......................................................................................347\u003c\/p\u003e\u003cp\u003e10.6.6 Australia.................................................................................348\u003c\/p\u003e\u003cp\u003e10.6.7 United Kingdom...................................................................349\u003c\/p\u003e\u003cp\u003e10.7 Pricing and Reimbursement Environment in the\u003c\/p\u003e\u003cp\u003eUnited States.......................................................................................349\u003c\/p\u003e\u003cp\u003e10.8 Value-Based Pricing (VBP) for Cancer Drugs................................350\u003c\/p\u003e\u003cp\u003e10.9 Risk-Sharing Scheme ........................................................................ 352\u003c\/p\u003e\u003cp\u003e10.10 The Future of Cost-Effectiveness of Cancer Treatments..............356\u003c\/p\u003e\u003cp\u003e10.10.1 Future Research: Methodology..........................................356\u003c\/p\u003e\u003cp\u003e10.10.2 Future Reimbursement Landscape....................................358\u003c\/p\u003e\u003cp\u003eBudget Impact Threshold................................................... 359\u003c\/p\u003e\u003cp\u003e10.10.2.1 Automatic Funding for Highly Specialized\u003c\/p\u003e\u003cp\u003eDrugs for Rare Diseases.....................................................359\u003c\/p\u003e\u003cp\u003e10.10.2.2 Fast-Track Appraisals......................................... 359\u003c\/p\u003e\u003cp\u003e10.11 Summary.............................................................................................360\u003c\/p\u003e\u003cp\u003e10.12 Exercises for Chapter 10....................................................................360\u003c\/p\u003e\u003cp\u003eReferences............................................................................................................ 361\u003c\/p\u003e\u003cp\u003eAdditional Bibliography.............................................................................. 394\u003c\/p\u003e\u003cp\u003eChapter 1............................................................................................. 394\u003c\/p\u003e\u003cp\u003eChapter 3............................................................................................. 395\u003c\/p\u003e\u003cp\u003eChapter 4............................................................................................. 395\u003c\/p\u003e\u003cp\u003eChapter 5............................................................................................. 399\u003c\/p\u003e\u003cp\u003eChapter 7............................................................................................. 399\u003c\/p\u003e\u003cp\u003eChapter 9............................................................................................. 399\u003c\/p\u003e\u003cp\u003eIndex\u003ci\u003e...................................................................................................................... \u003c\/i\u003e401\u003c\/p\u003e","brand":"Taylor \u0026 Francis Inc","offers":[{"title":"Default Title","offer_id":49372284879191,"sku":"9781498761307","price":82.5,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781498761307.jpg?v=1730162631"},{"product_id":"cancer-on-trial-9780226143040","title":"Cancer on Trial","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eHelps you explore how practitioners established a new style of practice, at the center of which lies the cancer clinical trial. Far from mere testing devices, this book features trials that have become full-fledged experiments that have redefined the practices of clinicians, statisticians, and biologists.","brand":"The University of Chicago Press","offers":[{"title":"Default Title","offer_id":49399954735447,"sku":"9780226143040","price":31.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780226143040.jpg?v=1730469259"},{"product_id":"toxicity-and-risk-context-principles-and-practice-9780415233712","title":"Toxicity and Risk Context Principles and Practice","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eThis book aims to set out the political, social, legal and scientific underpinning of risk assessment and risk management for toxic substances. It describes the principles and processes the practitioners undertake when looking at the regulatory risk implications of their work.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003ePreface -- Acknowledgements -- 1 Introduction -- PART I -- The context in which toxic risk analysis takes place -- 2 What risk management covers -- 3 Legal and organisational frameworks -- 4 Philosophical frameworks for handling risk -- 5 The importance of risk perception and risk -- communication for toxicological risk assessment -- PART II -- The principles and practice of toxic risk analysis -- 6 Introduction: Royal Society and National Academy of Sciences -- 7 Toxicological assessment -- 8 Evaluation of human health effects: toxicity -- 9 Evaluation of human health effects: exposure -- 10 The special case of major accident hazards -- 11 Evaluation of effects on the environment -- 12 Effects on the atmosphere -- References -- Appendix -- Index.","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":49402079576407,"sku":"9780415233712","price":73.14,"currency_code":"GBP","in_stock":true}]},{"product_id":"pharmaceutical-toxicology-9780853695936","title":"Pharmaceutical Toxicology","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eCovering areas of drug toxicity which address the major issues including registration requirements of new drugs and pharmacovigilance, this book provides an overview of the methodology and requirements of pre-clinical safety assessment of new medicines. It discusses mechanisms by which drugs cause toxic effects in living organisms.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e'The text is well written, concise and easy to understand with informative and helpful illustrations, figures and tables...it serves as an excellent companion to pharmacology textbooks, dealing with the issues relevant for assessing the safety of new drugs...a good starting point for the novice toxicologist, ambitious undergraduate student or graduate students working in the pharmaceutical sciences.' Irish Pharmacy Journal, November 2006, p418\u003c\/p\u003e * Irish Pharmacy Journal *\u003cbr\u003e\u003cp\u003e'...this is a great little book...the text is aimed primarily at new PHD students in the pharmaceutical and related sciences but could equally well serve taught postgraduate students on toxicology, clinical pharmacology, drug development and safety or similar courses. The book 'does exactly what it says on the tin' and will definitely whet the appetite of enthusiastic young researchers for toxicology.' Heather M Wallace, Summer 2007 issue of the British Toxicology Society Newsletter\u003c\/p\u003e -- Heather M Wallace * British Toxicology Society Newsletter *\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e1. General toxicology; 2. Drug metabolism: inactivation and bioactivation of xenobioptics; 3. Molecular and cellular mechanisms of toxicity; 4. Teratology; 5. Genotoxicity; 6. Carcinogenicity of drugs; 7. Liver toxicity; 8. Kidney toxicity; 9. Toxicology in the respiratory system; 10. Immunotoxicity; 11. Clinical toxicology; 12. Safety assessment of pharmaceuticals: regulatory aspects; 13. Pharmacovigilance.","brand":"Pharmaceutical Press","offers":[{"title":"Default Title","offer_id":49406262575447,"sku":"9780853695936","price":38.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780853695936.jpg?v=1730495149"},{"product_id":"success-probability-estimation-with-applications-to-clinical-trials-9781118335789","title":"Success Probability Estimation with Applications","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eWith a focus on estimating the success probability of an experiment, this book provides an introduction to the various statistical techniques involved in medical research and drug development   addressing the theoretical and practical aspects of the topic.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003eAcknowledgments xvii\u003c\/p\u003e \u003cp\u003eAcronyms xix\u003c\/p\u003e \u003cp\u003eIntroduction xxi\u003c\/p\u003e \u003cp\u003eI.1 Overview of clinical trials xxii\u003c\/p\u003e \u003cp\u003eI.2 Success rates of clinical trials xxiv\u003c\/p\u003e \u003cp\u003eI.3 Success probability xxv\u003c\/p\u003e \u003cp\u003eI.4 Starting from practice xxvii\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART I SUCCESS PROBABILITY ESTIMATION IN PLANNING AND ANALYZING CLINICAL TRIALS\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Basic statistical tools 3\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Pointwise estimation 4\u003c\/p\u003e \u003cp\u003e1.2 Confidence interval estimation, conservative estimation 6\u003c\/p\u003e \u003cp\u003e1.3 The statistical hypotheses, the statistical test and the type I error for one-tailed tests 10\u003c\/p\u003e \u003cp\u003e1.4 The power function and the type II error 11\u003c\/p\u003e \u003cp\u003e1.5 The p-value 14\u003c\/p\u003e \u003cp\u003e1.6 The success probability and its estimation 17\u003c\/p\u003e \u003cp\u003e1.7 Basic statistical tools for two tailed tests 19\u003c\/p\u003e \u003cp\u003e1.8 Other statistical hypotheses and tests 23\u003cbr\u003e \u003cb\u003e\u003cbr\u003e 2 Reproducibility Probability Estimation 25\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Pointwise RP estimation 26\u003c\/p\u003e \u003cp\u003e2.2 RP-testing 29\u003c\/p\u003e \u003cp\u003e2.3 The RP estimate and the \u003ci\u003ep\u003c\/i\u003e-value 32\u003c\/p\u003e \u003cp\u003e2.4 Statistical lower bounds for the RP 35\u003c\/p\u003e \u003cp\u003e2.5 The stability criterion for statistical significance 37\u003c\/p\u003e \u003cp\u003e2.6 Other stability criteria for statistical significance 40\u003c\/p\u003e \u003cp\u003e2.7 Comparing stability criteria 43\u003c\/p\u003e \u003cp\u003e2.8 Regulatory agencies and the single study 45\u003c\/p\u003e \u003cp\u003e2.9 The RP for two-tailed tests 46\u003c\/p\u003e \u003cp\u003e2.10 Discussing Situation I in Section I.4.1 49\u003cbr\u003e \u003cbr\u003e \u003cb\u003e3 Sample Size Estimation 51\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 The classical paradigm of sample size determination 52\u003c\/p\u003e \u003cp\u003e3.2 SP estimation for adapting the sample size 55\u003c\/p\u003e \u003cp\u003e3.3 Launching the trial in practice 57\u003c\/p\u003e \u003cp\u003e3.4 Practical aspects of SSE 60\u003c\/p\u003e \u003cp\u003e3.5 Frequentist conservative SSE 67\u003c\/p\u003e \u003cp\u003e3.6 Optimal frequentist CSSE 70\u003c\/p\u003e \u003cp\u003e3.7 Bayesian CSSE 75\u003c\/p\u003e \u003cp\u003e3.8 A comparison of CSSE strategies 80\u003c\/p\u003e \u003cp\u003e3.9 Discussing Situations I and II in Section I.4 83\u003c\/p\u003e \u003cp\u003e3.10 Sample size estimation for the two-tailed setting 85\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Robustness and Corrections in Sample Size Estimation 89\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 CSSE strategies with different effect sizes in phases II and III 90\u003c\/p\u003e \u003cp\u003e4.2 Comparing CSSE strategies in different Scenarios 91\u003c\/p\u003e \u003cp\u003e4.3 Corrections for CSSE strategies 94\u003c\/p\u003e \u003cp\u003e4.4 A comparison among Corrected CSSE strategies 97\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePART II SUCCESS PROBABILITY ESTIMATION FOR SOME WIDELY USED STATISTICAL TESTS\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 General parametric SP estimation 105\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 The parametric model 105\u003c\/p\u003e \u003cp\u003e5.2 Power, SP and noncentrality parameter estimation 106\u003c\/p\u003e \u003cp\u003e5.3 RP estimation and testing 107\u003c\/p\u003e \u003cp\u003e5.4 Sample size estimation 108\u003c\/p\u003e \u003cp\u003e5.5 Statistical tests included in the model 109\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 SP estimation for Student’s t statistical tests 113\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Test for two means equal variances 114\u003c\/p\u003e \u003cp\u003e6.1.1 Power and RP estimation 114\u003c\/p\u003e \u003cp\u003e6.2 Test for two means unequal variances 117\u003c\/p\u003e \u003cp\u003e6.3 On Student’s \u003ci\u003et\u003c\/i\u003e RP estimates 120\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 SP estimation for Gaussian distributed test statistics 123\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Test for two proportions 123\u003c\/p\u003e \u003cp\u003e7.2 Test for survival: the log-rank test 127\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 SP estimation for Chi-square statistical tests 133\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Test for two multinomial distributions: 2 x \u003ci\u003eC\u003c\/i\u003e comparative trial 133\u003c\/p\u003e \u003cp\u003e8.2 Test for S couples of binomial distributions: the Mantel-Haenszel test 137\u003c\/p\u003e \u003cp\u003e8.3 On χ\u003csup\u003e2\u003c\/sup\u003e RP estimates 141\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 General nonparametric SP estimation with - applications to the Wilcoxon test 143\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 The nonparametric model 144\u003c\/p\u003e \u003cp\u003e9.2 General nonparametric SP estimation 145\u003c\/p\u003e \u003cp\u003e9.3 The Wilcoxon rank-sum test 146\u003c\/p\u003e \u003cp\u003eA Tables of quantiles 161\u003c\/p\u003e \u003cp\u003eB Tables of RP estimates for the one-tailed \u003ci\u003eZ\u003c\/i\u003e test 169\u003c\/p\u003e \u003cp\u003eReferences 179\u003c\/p\u003e \u003cp\u003eTopic index 185\u003c\/p\u003e \u003cp\u003eAuthor index 193\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49406852006231,"sku":"9781118335789","price":999.99,"currency_code":"GBP","in_stock":false}]},{"product_id":"a-practical-guide-to-designing-phase-ii-trials-in-oncology-9781118570906","title":"A Practical Guide to Designing Phase II Trials in","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eA comprehensive and practical overview of the identification, conduct and analysis of optimal Phase II trial design.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eContributors xv\u003c\/p\u003e \u003cp\u003eForeword I xvii\u003cbr\u003e \u003ci\u003eElizabeth A. Eisenhauer\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eForeword II xix\u003cbr\u003e \u003ci\u003eRoger A’Hern\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003ePreface xxi\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction 1\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSarah Brown, Julia Brown, Walter Gregory and Chris Twelves\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e1.1 The role of phase II trials in cancer 3\u003c\/p\u003e \u003cp\u003e1.2 The importance of appropriate phase II trial design 5\u003c\/p\u003e \u003cp\u003e1.3 Current use of phase II designs 6\u003c\/p\u003e \u003cp\u003e1.4 Identifying appropriate phase II trial designs 7\u003c\/p\u003e \u003cp\u003e1.5 Potential trial designs 9\u003c\/p\u003e \u003cp\u003e1.6 Using the guidance to design your trial 10\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Key Points for Consideration 12\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSarah Brown, Julia Brown, Marc Buyse, Walter Gregory, Mahesh Parmar and Chris Twelves\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2.1 Stage 1 – Trial questions 14\u003c\/p\u003e \u003cp\u003e2.1.1 Therapeutic considerations 14\u003c\/p\u003e \u003cp\u003e2.1.2 Primary intention of trial 16\u003c\/p\u003e \u003cp\u003e2.1.3 Number of experimental treatment arms 17\u003c\/p\u003e \u003cp\u003e2.1.4 Primary outcome of interest 18\u003c\/p\u003e \u003cp\u003e2.2 Stage 2 – Design components 18\u003c\/p\u003e \u003cp\u003e2.2.1 Outcome measure and distribution 18\u003c\/p\u003e \u003cp\u003e2.2.2 Randomisation 21\u003c\/p\u003e \u003cp\u003e2.2.3 Design category 26\u003c\/p\u003e \u003cp\u003e2.3 Stage 3 – Practicalities 33\u003c\/p\u003e \u003cp\u003e2.3.1 Practical considerations 33\u003c\/p\u003e \u003cp\u003e2.4 Summary 35\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Designs for Single Experimental Therapies with a Single Arm 36\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSarah Brown\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3.1 One-stage designs 36\u003c\/p\u003e \u003cp\u003e3.1.1 Binary outcome measure 36\u003c\/p\u003e \u003cp\u003e3.1.2 Continuous outcome measure 38\u003c\/p\u003e \u003cp\u003e3.1.3 Multinomial outcome measure 39\u003c\/p\u003e \u003cp\u003e3.1.4 Time-to-event outcome measure 40\u003c\/p\u003e \u003cp\u003e3.1.5 Ratio of times to progression 40\u003c\/p\u003e \u003cp\u003e3.2 Two-stage designs 41\u003c\/p\u003e \u003cp\u003e3.2.1 Binary outcome measure 41\u003c\/p\u003e \u003cp\u003e3.2.2 Continuous outcome measure 50\u003c\/p\u003e \u003cp\u003e3.2.3 Multinomial outcome measure 50\u003c\/p\u003e \u003cp\u003e3.2.4 Time-to-event outcome measure 53\u003c\/p\u003e \u003cp\u003e3.2.5 Ratio of times to progression 54\u003c\/p\u003e \u003cp\u003e3.3 Multi-stage designs 55\u003c\/p\u003e \u003cp\u003e3.3.1 Binary outcome measure 55\u003c\/p\u003e \u003cp\u003e3.3.2 Continuous outcome measure 59\u003c\/p\u003e \u003cp\u003e3.3.3 Multinomial outcome measure 59\u003c\/p\u003e \u003cp\u003e3.3.4 Time-to-event outcome measure 60\u003c\/p\u003e \u003cp\u003e3.3.5 Ratio of times to progression 60\u003c\/p\u003e \u003cp\u003e3.4 Continuous monitoring designs 60\u003c\/p\u003e \u003cp\u003e3.4.1 Binary outcome measure 60\u003c\/p\u003e \u003cp\u003e3.4.2 Continuous outcome measure 63\u003c\/p\u003e \u003cp\u003e3.4.3 Multinomial outcome measure 63\u003c\/p\u003e \u003cp\u003e3.4.4 Time-to-event outcome measure 63\u003c\/p\u003e \u003cp\u003e3.4.5 Ratio of times to progression 64\u003c\/p\u003e \u003cp\u003e3.5 Decision-theoretic designs 64\u003c\/p\u003e \u003cp\u003e3.5.1 Binary outcome measure 64\u003c\/p\u003e \u003cp\u003e3.5.2 Continuous outcome measure 65\u003c\/p\u003e \u003cp\u003e3.5.3 Multinomial outcome measure 65\u003c\/p\u003e \u003cp\u003e3.5.4 Time-to-event outcome measure 65\u003c\/p\u003e \u003cp\u003e3.5.5 Ratio of times to progression 65\u003c\/p\u003e \u003cp\u003e3.6 Three-outcome designs 65\u003c\/p\u003e \u003cp\u003e3.6.1 Binary outcome measure 65\u003c\/p\u003e \u003cp\u003e3.6.2 Continuous outcome measure 66\u003c\/p\u003e \u003cp\u003e3.6.3 Multinomial outcome measure 66\u003c\/p\u003e \u003cp\u003e3.6.4 Time-to-event outcome measure 66\u003c\/p\u003e \u003cp\u003e3.6.5 Ratio of times to progression 67\u003c\/p\u003e \u003cp\u003e3.7 Phase II\/III designs 67\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Designs for Single Experimental Therapies Including Randomisation 68\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSarah Brown\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4.1 One-stage designs 68\u003c\/p\u003e \u003cp\u003e4.1.1 Binary outcome measure 68\u003c\/p\u003e \u003cp\u003e4.1.2 Continuous outcome measure 70\u003c\/p\u003e \u003cp\u003e4.1.3 Multinomial outcome measure 70\u003c\/p\u003e \u003cp\u003e4.1.4 Time-to-event outcome measure 70\u003c\/p\u003e \u003cp\u003e4.1.5 Ratio of times to progression 72\u003c\/p\u003e \u003cp\u003e4.2 Two-stage designs 72\u003c\/p\u003e \u003cp\u003e4.2.1 Binary outcome measure 72\u003c\/p\u003e \u003cp\u003e4.2.2 Continuous outcome measure 73\u003c\/p\u003e \u003cp\u003e4.2.3 Multinomial outcome measure 74\u003c\/p\u003e \u003cp\u003e4.2.4 Time-to-event outcome measure 75\u003c\/p\u003e \u003cp\u003e4.2.5 Ratio of times to progression 75\u003c\/p\u003e \u003cp\u003e4.3 Multi-stage designs 75\u003c\/p\u003e \u003cp\u003e4.3.1 Binary outcome measure 75\u003c\/p\u003e \u003cp\u003e4.3.2 Continuous outcome measure 75\u003c\/p\u003e \u003cp\u003e4.3.3 Multinomial outcome measure 75\u003c\/p\u003e \u003cp\u003e4.3.4 Time-to-event outcome measure 76\u003c\/p\u003e \u003cp\u003e4.3.5 Ratio of times to progression 76\u003c\/p\u003e \u003cp\u003e4.4 Continuous monitoring designs 76\u003c\/p\u003e \u003cp\u003e4.4.1 Binary outcome measure 76\u003c\/p\u003e \u003cp\u003e4.4.2 Continuous outcome measure 76\u003c\/p\u003e \u003cp\u003e4.4.3 Multinomial outcome measure 76\u003c\/p\u003e \u003cp\u003e4.4.4 Time-to-event outcome measure 76\u003c\/p\u003e \u003cp\u003e4.4.5 Ratio of times to progression 76\u003c\/p\u003e \u003cp\u003e4.5 Three-outcome designs 77\u003c\/p\u003e \u003cp\u003e4.5.1 Binary outcome measure 77\u003c\/p\u003e \u003cp\u003e4.5.2 Continuous outcome measure 77\u003c\/p\u003e \u003cp\u003e4.5.3 Multinomial outcome measure 77\u003c\/p\u003e \u003cp\u003e4.5.4 Time-to-event outcome measure 77\u003c\/p\u003e \u003cp\u003e4.5.5 Ratio of times to progression 77\u003c\/p\u003e \u003cp\u003e4.6 Phase II\/III designs 77\u003c\/p\u003e \u003cp\u003e4.6.1 Binary outcome measure 77\u003c\/p\u003e \u003cp\u003e4.6.2 Continuous outcome measure 79\u003c\/p\u003e \u003cp\u003e4.6.3 Multinomial outcome measure 80\u003c\/p\u003e \u003cp\u003e4.6.4 Time-to-event outcome measure 81\u003c\/p\u003e \u003cp\u003e4.6.5 Ratio of times to progression 81\u003c\/p\u003e \u003cp\u003e4.7 Randomised discontinuation designs 82\u003c\/p\u003e \u003cp\u003e4.7.1 Binary outcome measure 82\u003c\/p\u003e \u003cp\u003e4.7.2 Continuous outcome measure 82\u003c\/p\u003e \u003cp\u003e4.7.3 Multinomial outcome measure 82\u003c\/p\u003e \u003cp\u003e4.7.4 Time-to-event outcome measure 82\u003c\/p\u003e \u003cp\u003e4.7.5 Ratio of times to progression 82\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Treatment Selection Designs 83\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSarah Brown\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5.1 Including a control arm 84\u003c\/p\u003e \u003cp\u003e5.1.1 One-stage designs 84\u003c\/p\u003e \u003cp\u003e5.1.2 Two-stage designs 84\u003c\/p\u003e \u003cp\u003e5.1.3 Multi-stage designs 88\u003c\/p\u003e \u003cp\u003e5.1.4 Continuous monitoring designs 89\u003c\/p\u003e \u003cp\u003e5.1.5 Decision-theoretic designs 89\u003c\/p\u003e \u003cp\u003e5.1.6 Three-outcome designs 89\u003c\/p\u003e \u003cp\u003e5.1.7 Phase II\/III designs – same primary outcome measure at phase II and phase III 89\u003c\/p\u003e \u003cp\u003e5.1.8 Phase II\/III designs – different primary outcome measures at phase II and phase III 99\u003c\/p\u003e \u003cp\u003e5.1.9 Randomised discontinuation designs 102\u003c\/p\u003e \u003cp\u003e5.2 Not including a control arm 103\u003c\/p\u003e \u003cp\u003e5.2.1 One-stage designs 103\u003c\/p\u003e \u003cp\u003e5.2.2 Two-stage designs 106\u003c\/p\u003e \u003cp\u003e5.2.3 Multi-stage designs 108\u003c\/p\u003e \u003cp\u003e5.2.4 Continuous monitoring designs 109\u003c\/p\u003e \u003cp\u003e5.2.5 Decision-theoretic designs 110\u003c\/p\u003e \u003cp\u003e5.2.6 Three-outcome designs 110\u003c\/p\u003e \u003cp\u003e5.2.7 Phase II\/III designs – same primary outcome measure at phase II and phase III 110\u003c\/p\u003e \u003cp\u003e5.2.8 Randomised discontinuation designs 111\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Designs Incorporating Toxicity as a Primary Outcome 112\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSarah Brown\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6.1 Including a control arm 112\u003c\/p\u003e \u003cp\u003e6.1.1 One-stage designs 112\u003c\/p\u003e \u003cp\u003e6.1.2 Two-stage designs 114\u003c\/p\u003e \u003cp\u003e6.1.3 Multi-stage designs 115\u003c\/p\u003e \u003cp\u003e6.2 Not including a control arm 117\u003c\/p\u003e \u003cp\u003e6.2.1 One-stage designs 117\u003c\/p\u003e \u003cp\u003e6.2.2 Two-stage designs 118\u003c\/p\u003e \u003cp\u003e6.2.3 Multi-stage designs 122\u003c\/p\u003e \u003cp\u003e6.2.4 Continuous monitoring designs 125\u003c\/p\u003e \u003cp\u003e6.3 Toxicity alone 126\u003c\/p\u003e \u003cp\u003e6.3.1 One stage 126\u003c\/p\u003e \u003cp\u003e6.3.2 Continuous monitoring 127\u003c\/p\u003e \u003cp\u003e6.4 Treatment selection based on activity and toxicity 128\u003c\/p\u003e \u003cp\u003e6.4.1 Two-stage designs 128\u003c\/p\u003e \u003cp\u003e6.4.2 Multi-stage designs 129\u003c\/p\u003e \u003cp\u003e6.4.3 Continuous monitoring designs 129\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Designs Evaluating Targeted Subgroups 131\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSarah Brown\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7.1 One-stage designs 131\u003c\/p\u003e \u003cp\u003e7.1.1 Binary outcome measure 131\u003c\/p\u003e \u003cp\u003e7.2 Two-stage designs 132\u003c\/p\u003e \u003cp\u003e7.2.1 Binary outcome measure 132\u003c\/p\u003e \u003cp\u003e7.3 Multi-stage designs 135\u003c\/p\u003e \u003cp\u003e7.3.1 Binary outcome measure 135\u003c\/p\u003e \u003cp\u003e7.3.2 Time-to-event outcome measure 137\u003c\/p\u003e \u003cp\u003e7.4 Continuous monitoring designs 138\u003c\/p\u003e \u003cp\u003e7.4.1 Binary outcome measure 138\u003c\/p\u003e \u003cp\u003e7.4.2 Time-to-event outcome measure 139\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 ‘Chemo-radio-sensitisation’ in Head and Neck Cancer 141\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eJohn Chester and Sarah Brown\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eStage 1 – Trial questions 141\u003c\/p\u003e \u003cp\u003eTherapeutic considerations 141\u003c\/p\u003e \u003cp\u003ePrimary intention of trial 142\u003c\/p\u003e \u003cp\u003eNumber of experimental treatment arms 142\u003c\/p\u003e \u003cp\u003ePrimary outcome of interest 142\u003c\/p\u003e \u003cp\u003eStage 2 – Design components 142\u003c\/p\u003e \u003cp\u003eOutcome measure and distribution 142\u003c\/p\u003e \u003cp\u003eRandomisation 143\u003c\/p\u003e \u003cp\u003eDesign category 143\u003c\/p\u003e \u003cp\u003ePossible designs 144\u003c\/p\u003e \u003cp\u003eStage 3 – Practicalities 146\u003c\/p\u003e \u003cp\u003ePractical considerations for selecting between designs 146\u003c\/p\u003e \u003cp\u003eProposed trial design 148\u003c\/p\u003e \u003cp\u003eSummary 150\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Combination Chemotherapy in Second-line Treatment of Non-small Cell Lung Cancer 151\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eOrnella Belvedere and Sarah Brown\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eStage 1 – Trial questions 152\u003c\/p\u003e \u003cp\u003eTherapeutic considerations 152\u003c\/p\u003e \u003cp\u003ePrimary intention of trial 152\u003c\/p\u003e \u003cp\u003eNumber of experimental treatment arms 152\u003c\/p\u003e \u003cp\u003ePrimary outcome of interest 152\u003c\/p\u003e \u003cp\u003eStage 2 – Design components 153\u003c\/p\u003e \u003cp\u003eOutcome measure and distribution 153\u003c\/p\u003e \u003cp\u003eRandomisation 153\u003c\/p\u003e \u003cp\u003eDesign category 153\u003c\/p\u003e \u003cp\u003ePossible designs 154\u003c\/p\u003e \u003cp\u003eStage 3 – Practicalities 155\u003c\/p\u003e \u003cp\u003ePractical considerations for selecting between designs 155\u003c\/p\u003e \u003cp\u003eProposed trial design 158\u003c\/p\u003e \u003cp\u003eSummary 162\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Selection by Biomarker in Prostate Cancer 163\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eRick Kaplan and Sarah Brown\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eStage 1 – Trial questions 164\u003c\/p\u003e \u003cp\u003eTherapeutic considerations 164\u003c\/p\u003e \u003cp\u003ePrimary intention of trial 164\u003c\/p\u003e \u003cp\u003eNumber of experimental treatment arms 164\u003c\/p\u003e \u003cp\u003ePrimary outcome of interest 164\u003c\/p\u003e \u003cp\u003eStage 2 – Design components 165\u003c\/p\u003e \u003cp\u003eOutcome measure and distribution 165\u003c\/p\u003e \u003cp\u003eRandomisation 165\u003c\/p\u003e \u003cp\u003eDesign category 166\u003c\/p\u003e \u003cp\u003ePossible designs 167\u003c\/p\u003e \u003cp\u003eStage 3 – Practicalities 168\u003c\/p\u003e \u003cp\u003ePractical considerations for selecting between designs 168\u003c\/p\u003e \u003cp\u003eProposed trial design 170\u003c\/p\u003e \u003cp\u003eSummary 171\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Dose Selection in Advanced Multiple Myeloma 174\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSarah Brown and Steve Schey\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eStage 1 – Trial questions 174\u003c\/p\u003e \u003cp\u003eTherapeutic considerations 174\u003c\/p\u003e \u003cp\u003ePrimary intention of trial 175\u003c\/p\u003e \u003cp\u003eNumber of experimental arms 175\u003c\/p\u003e \u003cp\u003ePrimary outcome of interest 175\u003c\/p\u003e \u003cp\u003eStage 2 – Design components 176\u003c\/p\u003e \u003cp\u003eOutcome measure and distribution 176\u003c\/p\u003e \u003cp\u003eRandomisation 176\u003c\/p\u003e \u003cp\u003eDesign category 177\u003c\/p\u003e \u003cp\u003ePossible designs 177\u003c\/p\u003e \u003cp\u003eStage 3 – Practicalities 178\u003c\/p\u003e \u003cp\u003ePractical considerations for selecting between designs 178\u003c\/p\u003e \u003cp\u003eProposed trial design 181\u003c\/p\u003e \u003cp\u003eSummary 182\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Targeted Therapy for Advanced Colorectal Cancer 185\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eMatthew Seymour and Sarah Brown\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eStage 1 – Trial questions 185\u003c\/p\u003e \u003cp\u003eTherapeutic considerations 185\u003c\/p\u003e \u003cp\u003ePrimary intention of trial 186\u003c\/p\u003e \u003cp\u003eNumber of experimental treatment arms 186\u003c\/p\u003e \u003cp\u003ePrimary outcome of interest 186\u003c\/p\u003e \u003cp\u003eStage 2 – Design components 187\u003c\/p\u003e \u003cp\u003eOutcome measure and distribution 187\u003c\/p\u003e \u003cp\u003eRandomisation 187\u003c\/p\u003e \u003cp\u003eDesign category 188\u003c\/p\u003e \u003cp\u003ePossible designs 189\u003c\/p\u003e \u003cp\u003eStage 3 – Practicalities 190\u003c\/p\u003e \u003cp\u003ePractical considerations for selecting between designs 190\u003c\/p\u003e \u003cp\u003eProposed trial design 191\u003c\/p\u003e \u003cp\u003eSummary 194\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Phase II Oncology Trials: Perspective from Industry 195\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAnthony Rossini, Steven Green and William Mietlowski\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 195\u003c\/p\u003e \u003cp\u003e13.2 Commercial challenges, drivers and considerations 196\u003c\/p\u003e \u003cp\u003e13.3 Selecting designs by strategy 197\u003c\/p\u003e \u003cp\u003e13.3.1 Basic strategies addressed by phase II studies 198\u003c\/p\u003e \u003cp\u003e13.3.2 Potential registration 198\u003c\/p\u003e \u003cp\u003e13.3.3 Exploratory activity 203\u003c\/p\u003e \u003cp\u003e13.3.4 Regimen selection 204\u003c\/p\u003e \u003cp\u003e13.3.5 Phase II to Support Predicting Success in Phase IIi 206\u003c\/p\u003e \u003cp\u003e13.3.6 Phase II safety trials 208\u003c\/p\u003e \u003cp\u003e13.3.7 Prospective identification of target populations 209\u003c\/p\u003e \u003cp\u003e13.4 Discussion 210\u003c\/p\u003e \u003cp\u003eReferences 213\u003c\/p\u003e \u003cp\u003eIndex 227 \u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49406891229527,"sku":"9781118570906","price":52.2,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781118570906.jpg?v=1730497461"},{"product_id":"randomization-in-clinical-trials-9781118742242","title":"Randomization in Clinical Trials","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cb\u003ePraise for the \u003ci\u003eFirst Edition\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAll medical statisticians involved in clinical trials should read this book\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e- \u003ci\u003eControlled Clinical Trials\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eFeaturing a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, \u003ci\u003eRandomization in Clinical Trials:\u003c\/i\u003e \u003ci\u003eTheory and Practice, Second Edition \u003c\/i\u003eis the go-to guide for biostatisticians and pharmaceutical industry statisticians.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eRandomization in Clinical Trials: Theory and Practice, Second Edition \u003c\/i\u003efeatures:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eDiscussions on current philosophies, controversies, and new developments in the increasingly important role of randomization techniques in clinical trials\u003c\/li\u003e \u003cli\u003eA new chapter on covariate-adaptive randomization, including minimization techniques and inference\u003c\/li\u003e \u003cli\u003eNew developments in restricted randomization and an increased focus on computation of randomization tests as opposed to the asy\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\"Featuring a unique combination of the applied aspects of randomization in clinical trials with a nonparametric approach to inference, the book is the go-to guide for biostatisticians and pharmaceutical industry statisticians.\" (Zentralblatt MATH 2016)\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePreface xi\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Randomization and the Clinical Trial 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 1\u003c\/p\u003e \u003cp\u003e1.2 Causation and Association 2\u003c\/p\u003e \u003cp\u003e1.3 Randomized Clinical Trials 6\u003c\/p\u003e \u003cp\u003e1.4 Ethics of Randomization 9\u003c\/p\u003e \u003cp\u003e1.5 Problems 12\u003c\/p\u003e \u003cp\u003e1.6 References 13\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Issues in the Design of Clinical Trials 15\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 15\u003c\/p\u003e \u003cp\u003e2.2 Study Outcomes 15\u003c\/p\u003e \u003cp\u003e2.3 Sources of Bias 18\u003c\/p\u003e \u003cp\u003e2.3.1 Selection and ascertainment bias 19\u003c\/p\u003e \u003cp\u003e2.3.2 Statistical analysis philosophy 20\u003c\/p\u003e \u003cp\u003e2.3.3 Losses to follow-up and noncompliance 21\u003c\/p\u003e \u003cp\u003e2.3.4 Covariates 21\u003c\/p\u003e \u003cp\u003e2.4 Experimental Design 23\u003c\/p\u003e \u003cp\u003e2.5 Recruitment and Follow-Up 25\u003c\/p\u003e \u003cp\u003e2.6 Determining the Number of Randomized Subjects 26\u003c\/p\u003e \u003cp\u003e2.6.1 Development of the main formula 27\u003c\/p\u003e \u003cp\u003e2.6.2 Example 29\u003c\/p\u003e \u003cp\u003e2.6.3 Survival trials 29\u003c\/p\u003e \u003cp\u003e2.6.4 Adjustment for noncompliance 32\u003c\/p\u003e \u003cp\u003e2.6.5 Additional considerations 32\u003c\/p\u003e \u003cp\u003e2.7 Problems 33\u003c\/p\u003e \u003cp\u003e2.8 References 34\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Randomization for Balancing Treatment Assignments 37\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 37\u003c\/p\u003e \u003cp\u003e3.2 Complete Randomization 38\u003c\/p\u003e \u003cp\u003e3.3 Forced Balance Procedures 40\u003c\/p\u003e \u003cp\u003e3.3.1 Random allocation rule 40\u003c\/p\u003e \u003cp\u003e3.3.2 Truncated binomial design 42\u003c\/p\u003e \u003cp\u003e3.3.3 Hadamard randomization 44\u003c\/p\u003e \u003cp\u003e3.3.4 Maximal procedure 46\u003c\/p\u003e \u003cp\u003e3.4 Forced Balance Randomization Within Blocks 46\u003c\/p\u003e \u003cp\u003e3.4.1 Permuted block design 46\u003c\/p\u003e \u003cp\u003e3.4.2 Random block design 47\u003c\/p\u003e \u003cp\u003e3.5 Efron’s Biased Coin Design 48\u003c\/p\u003e \u003cp\u003e3.6 Other Biased Coin Designs and Generalizations 51\u003c\/p\u003e \u003cp\u003e3.7 Wei’s Urn Design 52\u003c\/p\u003e \u003cp\u003e3.8 Other urn Models and Generalizations 54\u003c\/p\u003e \u003cp\u003e3.9 Comparison of Balancing Properties 55\u003c\/p\u003e \u003cp\u003e3.10 Restricted Randomization for Unbalanced Allocation 58\u003c\/p\u003e \u003cp\u003e3.11 \u003ci\u003eK\u003c\/i\u003e \u0026gt; 2 Treatments 61\u003c\/p\u003e \u003cp\u003e3.12 Problems 62\u003c\/p\u003e \u003cp\u003e3.13 References 64\u003c\/p\u003e \u003cp\u003e3.14 Appendix 66\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 The Effects of Unobserved Covariates 67\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 67\u003c\/p\u003e \u003cp\u003e4.2 A Bound on the Probability of a Covariate Imbalance 68\u003c\/p\u003e \u003cp\u003e4.3 Simulation Results 70\u003c\/p\u003e \u003cp\u003e4.4 Accidental Bias 71\u003c\/p\u003e \u003cp\u003e4.5 Maximum Eigenvalue of 𝚺T 73\u003c\/p\u003e \u003cp\u003e4.6 Accidental Bias for Biased Coin Designs 74\u003c\/p\u003e \u003cp\u003e4.7 Chronological Bias 75\u003c\/p\u003e \u003cp\u003e4.8 Problems 76\u003c\/p\u003e \u003cp\u003e4.9 References 76\u003c\/p\u003e \u003cp\u003e4.10 Appendix 77\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Selection Bias 79\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 79\u003c\/p\u003e \u003cp\u003e5.2 The Blackwell–Hodges Model 81\u003c\/p\u003e \u003cp\u003e5.3 Predictability of a Randomization Sequence 83\u003c\/p\u003e \u003cp\u003e5.4 Selection Bias for the Random Allocation Rule and Truncated Binomial Design 84\u003c\/p\u003e \u003cp\u003e5.5 Selection Bias in a Permuted Block Design 87\u003c\/p\u003e \u003cp\u003e5.5.1 Permuted blocks using the random allocation rule 87\u003c\/p\u003e \u003cp\u003e5.5.2 Permuted blocks with truncated binomial randomization 87\u003c\/p\u003e \u003cp\u003e5.5.3 Random block design 87\u003c\/p\u003e \u003cp\u003e5.5.4 Conclusions 89\u003c\/p\u003e \u003cp\u003e5.6 Selection Bias for Other Restricted Randomization Procedures 90\u003c\/p\u003e \u003cp\u003e5.6.1 Efron’s biased coin design 90\u003c\/p\u003e \u003cp\u003e5.6.2 Wei’s urn design 90\u003c\/p\u003e \u003cp\u003e5.6.3 Smith’s design 91\u003c\/p\u003e \u003cp\u003e5.7 Simulation Results 91\u003c\/p\u003e \u003cp\u003e5.8 Controlling and Testing for Selection Bias in Practice 93\u003c\/p\u003e \u003cp\u003e5.9 Problems 94\u003c\/p\u003e \u003cp\u003e5.10 References 94\u003c\/p\u003e \u003cp\u003e5.11 Appendix 95\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Randomization as a Basis for Inference 97\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 97\u003c\/p\u003e \u003cp\u003e6.2 The Population Model 97\u003c\/p\u003e \u003cp\u003e6.3 The Randomization Model 100\u003c\/p\u003e \u003cp\u003e6.4 Randomization Tests 103\u003c\/p\u003e \u003cp\u003e6.5 Linear Rank Tests 105\u003c\/p\u003e \u003cp\u003e6.6 Variance of the Linear Rank Test 108\u003c\/p\u003e \u003cp\u003e6.7 Optimal Rank Scores 110\u003c\/p\u003e \u003cp\u003e6.8 Exact and Large-Sample Randomization Tests 111\u003c\/p\u003e \u003cp\u003e6.8.1 Computation of exact tests 112\u003c\/p\u003e \u003cp\u003e6.8.2 Large sample randomization tests 113\u003c\/p\u003e \u003cp\u003e6.9 Monte Carlo Re-Randomization Tests 115\u003c\/p\u003e \u003cp\u003e6.9.1 Unconditional tests 115\u003c\/p\u003e \u003cp\u003e6.9.2 Example 116\u003c\/p\u003e \u003cp\u003e6.9.3 Conditional tests 117\u003c\/p\u003e \u003cp\u003e6.10 Preservation of Error Rates 118\u003c\/p\u003e \u003cp\u003e6.11 Regression Modeling 120\u003c\/p\u003e \u003cp\u003e6.12 Analyses with Missing Data 121\u003c\/p\u003e \u003cp\u003e6.13 Sample Size Considerations for Random Sample Fractions 122\u003c\/p\u003e \u003cp\u003e6.14 Group Sequential Monitoring 123\u003c\/p\u003e \u003cp\u003e6.14.1 Establishing a stopping boundary 124\u003c\/p\u003e \u003cp\u003e6.14.2 Information fraction 125\u003c\/p\u003e \u003cp\u003e6.15 Problems 126\u003c\/p\u003e \u003cp\u003e6.16 References 127\u003c\/p\u003e \u003cp\u003e6.17 Appendix A 129\u003c\/p\u003e \u003cp\u003e6.18 Appendix B 131\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Stratification 133\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 133\u003c\/p\u003e \u003cp\u003e7.2 Stratified Randomization 134\u003c\/p\u003e \u003cp\u003e7.3 Is Stratification Necessary? 135\u003c\/p\u003e \u003cp\u003e7.4 Treatment Imbalances in Stratified Trials 136\u003c\/p\u003e \u003cp\u003e7.5 Stratified Analysis Using Randomization Tests 138\u003c\/p\u003e \u003cp\u003e7.6 Efficiency of Stratified Randomization in a Stratified Analysis 140\u003c\/p\u003e \u003cp\u003e7.7 Conclusions 144\u003c\/p\u003e \u003cp\u003e7.8 Problems 144\u003c\/p\u003e \u003cp\u003e7.9 References 145\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Restricted Randomization in Practice 147\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 147\u003c\/p\u003e \u003cp\u003e8.2 Stratification 148\u003c\/p\u003e \u003cp\u003e8.3 Characteristics of Randomization Procedures 149\u003c\/p\u003e \u003cp\u003e8.3.1 Consideration of selection bias 149\u003c\/p\u003e \u003cp\u003e8.3.2 Implications for analysis 151\u003c\/p\u003e \u003cp\u003e8.4 Selecting a Randomization Procedure 151\u003c\/p\u003e \u003cp\u003e8.4.1 Choosing parameter values 152\u003c\/p\u003e \u003cp\u003e8.4.2 Comparing procedures 153\u003c\/p\u003e \u003cp\u003e8.4.3 Conclusions 156\u003c\/p\u003e \u003cp\u003e8.5 Generation of Sequences 156\u003c\/p\u003e \u003cp\u003e8.6 Implementation 157\u003c\/p\u003e \u003cp\u003e8.6.1 Packaging and labeling 158\u003c\/p\u003e \u003cp\u003e8.6.2 The actual randomization 159\u003c\/p\u003e \u003cp\u003e8.7 Special Situations 160\u003c\/p\u003e \u003cp\u003e8.8 Some Examples 163\u003c\/p\u003e \u003cp\u003e8.8.1 The optic neuritis treatment trial 163\u003c\/p\u003e \u003cp\u003e8.8.2 Vesnarinone in congestive heart failure 163\u003c\/p\u003e \u003cp\u003e8.8.3 The diabetes control and complications trial 163\u003c\/p\u003e \u003cp\u003e8.8.4 Captopril in diabetic nephropathy 164\u003c\/p\u003e \u003cp\u003e8.8.5 The diabetes prevention program 164\u003c\/p\u003e \u003cp\u003e8.8.6 Scleral buckling versus primary vitrectomy in retinal detachment (The SPR Study) 164\u003c\/p\u003e \u003cp\u003e8.9 Problems 165\u003c\/p\u003e \u003cp\u003e8.10 References 166\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Covariate-Adaptive Randomization 169\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Early Work 169\u003c\/p\u003e \u003cp\u003e9.1.1 Zelen’s rule 170\u003c\/p\u003e \u003cp\u003e9.1.2 The Pocock–Simon procedure 170\u003c\/p\u003e \u003cp\u003e9.1.3 Example: Adjuvant chemotherapy for locally invasive bladder cancer 171\u003c\/p\u003e \u003cp\u003e9.1.4 Wei’s marginal urn design 171\u003c\/p\u003e \u003cp\u003e9.1.5 Is marginal balance sufficient? 171\u003c\/p\u003e \u003cp\u003e9.1.6 Is randomization necessary? 172\u003c\/p\u003e \u003cp\u003e9.2 More Recent Covariate-Adaptive Randomization Procedures 173\u003c\/p\u003e \u003cp\u003e9.2.1 Balancing within strata 173\u003c\/p\u003e \u003cp\u003e9.2.2 Balancing with respect to continuous covariates 174\u003c\/p\u003e \u003cp\u003e9.3 Optimal Design Based on a Linear Model 175\u003c\/p\u003e \u003cp\u003e9.4 The Trade-Off Among Balance, Efficiency, and Ethics 177\u003c\/p\u003e \u003cp\u003e9.5 Inference for Covariate-Adaptive Randomization 179\u003c\/p\u003e \u003cp\u003e9.5.1 Model-based inference 179\u003c\/p\u003e \u003cp\u003e9.5.2 Randomization-based inference 180\u003c\/p\u003e \u003cp\u003e9.6 Conclusions 181\u003c\/p\u003e \u003cp\u003e9.7 Problems 182\u003c\/p\u003e \u003cp\u003e9.8 References 185\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Response-Adaptive Randomization 189\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 189\u003c\/p\u003e \u003cp\u003e10.2 Historical Notes 190\u003c\/p\u003e \u003cp\u003e10.2.1 Roots in bandit problems 190\u003c\/p\u003e \u003cp\u003e10.2.2 Roots in sequential stopping problems 191\u003c\/p\u003e \u003cp\u003e10.2.3 Roots in randomization 192\u003c\/p\u003e \u003cp\u003e10.3 Optimal Allocation 193\u003c\/p\u003e \u003cp\u003e10.4 Response-Adaptive Randomization to Target R∗ 196\u003c\/p\u003e \u003cp\u003e10.4.1 Sequential maximum likelihood procedure 196\u003c\/p\u003e \u003cp\u003e10.4.2 Doubly adaptive biased coin design 198\u003c\/p\u003e \u003cp\u003e10.4.3 Example 200\u003c\/p\u003e \u003cp\u003e10.4.4 Efficient randomized-adaptive design 201\u003c\/p\u003e \u003cp\u003e10.5 Urn Models 201\u003c\/p\u003e \u003cp\u003e10.5.1 The generalized Friedman’s urn model 201\u003c\/p\u003e \u003cp\u003e10.5.2 The randomized play-the-winner rule 202\u003c\/p\u003e \u003cp\u003e10.5.3 Designs to target any allocation 205\u003c\/p\u003e \u003cp\u003e10.5.4 Ternary urn models 206\u003c\/p\u003e \u003cp\u003e10.5.5 Klein urn 207\u003c\/p\u003e \u003cp\u003e10.6 Treatment Effect Mappings 207\u003c\/p\u003e \u003cp\u003e10.7 Covariate-Adjusted Response-Adaptive Randomization 208\u003c\/p\u003e \u003cp\u003e10.8 Problems 209\u003c\/p\u003e \u003cp\u003e10.9 References 211\u003c\/p\u003e \u003cp\u003e10.10 Appendix 214\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Inference for Response-Adaptive Randomization 217\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 217\u003c\/p\u003e \u003cp\u003e11.2 Population-Based Inference 217\u003c\/p\u003e \u003cp\u003e11.2.1 The likelihood 217\u003c\/p\u003e \u003cp\u003e11.2.2 Sufficiency 220\u003c\/p\u003e \u003cp\u003e11.2.3 Bias of the maximum likelihood estimators 220\u003c\/p\u003e \u003cp\u003e11.2.4 Confidence interval procedures 222\u003c\/p\u003e \u003cp\u003e11.3 Power 223\u003c\/p\u003e \u003cp\u003e11.3.1 The relationship between power and the variability of the design 223\u003c\/p\u003e \u003cp\u003e11.3.2 Asymptotically best procedures 225\u003c\/p\u003e \u003cp\u003e11.3.3 Response-adaptive randomization and sequential monitoring 226\u003c\/p\u003e \u003cp\u003e11.4 Randomization-Based Inference 226\u003c\/p\u003e \u003cp\u003e11.5 Problems 228\u003c\/p\u003e \u003cp\u003e11.6 References 228\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Response-Adaptive Randomization in Practice 231\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Basic Assumptions 231\u003c\/p\u003e \u003cp\u003e12.2 Bias, Masking, and Consent 232\u003c\/p\u003e \u003cp\u003e12.3 Logistical Issues 233\u003c\/p\u003e \u003cp\u003e12.4 Selection of A Procedure 234\u003c\/p\u003e \u003cp\u003e12.5 Benefits of Response-Adaptive Randomization 236\u003c\/p\u003e \u003cp\u003e12.6 Some Examples 237\u003c\/p\u003e \u003cp\u003e12.6.1 The extracorporeal membrane oxygenation trial 237\u003c\/p\u003e \u003cp\u003e12.6.2 The fluoxetine trial 238\u003c\/p\u003e \u003cp\u003e12.7 Conclusions 239\u003c\/p\u003e \u003cp\u003e12.8 Problems 240\u003c\/p\u003e \u003cp\u003e12.9 References 240\u003c\/p\u003e \u003cp\u003eAuthor Index 243\u003c\/p\u003e \u003cp\u003eSubject Index 249\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49406914658647,"sku":"9781118742242","price":93.56,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781118742242.jpg?v=1730497544"},{"product_id":"handbook-for-clinical-trials-of-imaging-and-imageguided-interventions-9781118849750","title":"Handbook for Clinical Trials of Imaging and","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eThis book focuses on educating radiologists, radiation oncologists and others interested in imaging research about how to design and conduct clinical trials to evaluate imaging technology and imaging biomarkers.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eContributors, vi\u003c\/p\u003e \u003cp\u003eChapter 1 Imaging technology assessment, 1\u003cbr\u003e\u003ci\u003ePari V. Pandharipande and G. Scott Gazelle\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 2 Clinical trials of therapy, 10\u003cbr\u003e\u003ci\u003eSayeh Lavasani, Anthony F. Shields and Ali Mahinbakht\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 3 Clinical trials of image]guided interventions including radiotherapy studies, 29\u003cbr\u003e\u003ci\u003eGary S. Dorfman and\u003c\/i\u003e \u003ci\u003eStephen M. Hahn\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 4 Imaging as a predictor of therapeutic response, 57\u003cbr\u003e\u003ci\u003eDavid A. Mankoff and Anthony F. Shields\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 5 Screening trials and design, 76\u003cbr\u003e\u003ci\u003eJanie M. Lee, Constance D. Lehman and Diana L. Miglioretti\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 6 Practicalities of running a clinical trial, 91\u003cbr\u003e\u003ci\u003eMichael T. Lu, Elizabeth C. Adami and Udo Hoffmann\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 7 Statistical issues in study design, 103\u003cbr\u003e\u003ci\u003eNancy A. Obuchowski\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 8 Introduction to biostatistical methods, 126\u003cbr\u003e\u003ci\u003eDiana L. Miglioretti, Todd A. Alonzo and Nancy A. Obuchowski\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 9 Methods for studies of diagnostic tests, 147\u003cbr\u003e\u003ci\u003eJeffrey D. Blume\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 10 Methods for quantitative imaging biomarker studies, 170\u003cbr\u003e\u003ci\u003eAlicia Y. Toledano and Nancy A. Obuchowski\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eChapter 11 Introduction to cost]effectiveness analysis in clinical trials, 189\u003cbr\u003e\u003ci\u003eRuth C. Carlos and G. Scott Gazelle\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex, 208\u003c\/p\u003e","brand":"John Wiley and Sons Ltd","offers":[{"title":"Default Title","offer_id":49406934483287,"sku":"9781118849750","price":82.6,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781118849750.jpg?v=1730497608"},{"product_id":"drugs-9781118907276","title":"Drugs","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eThe third edition of this best-selling book continues to offer a user-friendly, step-by-step introduction to all the key processes involved in bringing a drug to the market, including the performance of pre-clinical studies, the conduct of human clinical trials, regulatory controls, and even the manufacturing processes for pharmaceutical products.\u003c\/p\u003e Concise and easy to read, \u003ci\u003eDrugs: From Discovery to Approval, Third Edition\u003c\/i\u003e quickly introduces basic concepts, then moves on to discuss target selection and the drug discovery process for both small and large molecular drugs. The third edition incorporates the latest developments and updates in the pharmaceutical community, provides more comprehensive coverage of topics, and includes more materials and case studies suited to college and university use. Biotechnology is a dynamic field with changes across R\u0026amp;D, clinical trials, manufacturing and regulatory processes, and the third edition of the text provides timely updates for tho\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Aim of this Book 1\u003c\/p\u003e \u003cp\u003e1.2 An Overview of the Drug Discovery to Approval Process 2\u003c\/p\u003e \u003cp\u003e1.3 The Pharmaceutical Industry 6\u003c\/p\u003e \u003cp\u003e1.4 Economics of Drug Discovery and Development 11\u003c\/p\u003e \u003cp\u003e1.5 Trends in Drug Discovery and Development 13\u003c\/p\u003e \u003cp\u003e1.6 Case Study #1.1 15\u003c\/p\u003e \u003cp\u003e1.7 Case Study #1.2 17\u003c\/p\u003e \u003cp\u003e1.8 Summary of Important Points 20\u003c\/p\u003e \u003cp\u003e1.9 Review Questions 20\u003c\/p\u003e \u003cp\u003e1.10 Brief Answers and Explanations 21\u003c\/p\u003e \u003cp\u003e1.11 Further Reading 22\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Drug Discovery: Targets and Receptors 23\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Drug Discovery Processes 23\u003c\/p\u003e \u003cp\u003e2.2 Medical Needs 24\u003c\/p\u003e \u003cp\u003e2.3 Target Identification 26content\u003c\/p\u003e \u003cp\u003e2.4 Target Validation 33\u003c\/p\u003e \u003cp\u003e2.5 Drug Interactions with Targets or Receptors 36\u003c\/p\u003e \u003cp\u003e2.6 Enzymes 40\u003c\/p\u003e \u003cp\u003e2.7 Receptors and Signal Transduction 42\u003c\/p\u003e \u003cp\u003e2.8 Assay Development 52\u003c\/p\u003e \u003cp\u003e2.9 Case Study #2.1 52\u003c\/p\u003e \u003cp\u003e2.10 Case Study #2.2 53\u003c\/p\u003e \u003cp\u003e2.11 Summary of Important Points 57\u003c\/p\u003e \u003cp\u003e2.12 Review Questions 57\u003c\/p\u003e \u003cp\u003e2.13 Brief Answers and Explanations 58\u003c\/p\u003e \u003cp\u003e2.14 Further Reading 58\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Drug Discovery: Small Molecule Drugs 61\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 61\u003c\/p\u003e \u003cp\u003e3.2 Irrational Approach 62\u003c\/p\u003e \u003cp\u003e3.3 Rational Approach 67\u003c\/p\u003e \u003cp\u003e3.4 Antisense Approach 85\u003c\/p\u003e \u003cp\u003e3.5 RNA Interference Approach 88\u003c\/p\u003e \u003cp\u003e3.6 Chiral Drugs 91\u003c\/p\u003e \u003cp\u003e3.7 Closing Remarks 92\u003c\/p\u003e \u003cp\u003e3.8 Case Study #3.1 94\u003c\/p\u003e \u003cp\u003e3.9 Case Study #3.2 96\u003c\/p\u003e \u003cp\u003e3.10 Summary of Important Points 98\u003c\/p\u003e \u003cp\u003e3.11 Review Questions 99\u003c\/p\u003e \u003cp\u003e3.12 Brief Answers and Explanations 99\u003c\/p\u003e \u003cp\u003e3.13 Further Reading 100\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Drug Discovery: Large Molecule Drugs 103\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 103\u003c\/p\u003e \u003cp\u003e4.2 Vaccines 105\u003c\/p\u003e \u003cp\u003e4.3 Antibodies 117\u003c\/p\u003e \u003cp\u003e4.4 Cytokines 128\u003c\/p\u003e \u003cp\u003e4.5 Hormones 134\u003c\/p\u003e \u003cp\u003e4.6 Gene Therapy 137\u003c\/p\u003e \u003cp\u003e4.7 Stem Cells and Cell Therapy 139\u003c\/p\u003e \u003cp\u003e4.8 Case Study #4.1 141\u003c\/p\u003e \u003cp\u003e4.9 Case Study #4.2 144\u003c\/p\u003e \u003cp\u003e4.10 Summary of Important Points 146\u003c\/p\u003e \u003cp\u003e4.11 Review Questions 147\u003c\/p\u003e \u003cp\u003e4.12 Brief Answers and Explanations 148\u003c\/p\u003e \u003cp\u003e4.13 Further Reading 148\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Drug Development and Preclinical Studies 151\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 151\u003c\/p\u003e \u003cp\u003e5.2 Pharmacodynamics 154\u003c\/p\u003e \u003cp\u003e5.3 Pharmacokinetics 158\u003c\/p\u003e \u003cp\u003e5.4 Toxicology 168\u003c\/p\u003e \u003cp\u003e5.5 Animal Tests, \u003ci\u003eIn Vitro \u003c\/i\u003eAssays, and \u003ci\u003eIn Silico \u003c\/i\u003eMethods 172\u003c\/p\u003e \u003cp\u003e5.6 Formulations and Delivery Systems 175\u003c\/p\u003e \u003cp\u003e5.7 Nanotechnology 183\u003c\/p\u003e \u003cp\u003e5.8 Case Study #5.1 184\u003c\/p\u003e \u003cp\u003e5.9 Case Study #5.2 185\u003c\/p\u003e \u003cp\u003e5.10 Summary of Important Points 187\u003c\/p\u003e \u003cp\u003e5.11 Review Questions 188\u003c\/p\u003e \u003cp\u003e5.12 Brief Answers and Explanations 188\u003c\/p\u003e \u003cp\u003e5.13 Further Reading 189\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Clinical Trials 191\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Definition of Clinical Trial 191\u003c\/p\u003e \u003cp\u003e6.2 Ethical Considerations 192\u003c\/p\u003e \u003cp\u003e6.3 Clinical Trials 195\u003c\/p\u003e \u003cp\u003e6.4 Regulatory Requirements for Clinical Trials 204\u003c\/p\u003e \u003cp\u003e6.5 Clinical Data Management 215\u003c\/p\u003e \u003cp\u003e6.6 Role of Regulatory Authorities 218\u003c\/p\u003e \u003cp\u003e6.7 Gene Therapy Clinical Trial 218\u003c\/p\u003e \u003cp\u003e6.8 Adaptive Clinical Trial 220\u003c\/p\u003e \u003cp\u003e6.9 Meta-Analysis 221\u003c\/p\u003e \u003cp\u003e6.10 Case Study #6.1 222\u003c\/p\u003e \u003cp\u003e6.11 Case Study #6.2 226\u003c\/p\u003e \u003cp\u003e6.12 Summary of Important Points 227\u003c\/p\u003e \u003cp\u003e6.13 Review Questions 228\u003c\/p\u003e \u003cp\u003e6.14 Brief Answers and Explanations 228\u003c\/p\u003e \u003cp\u003e6.15 Further Reading 229\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Regulatory Authorities 231\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Role of Regulatory Authorities 231\u003c\/p\u003e \u003cp\u003e7.2 US Food and Drug Administration 233\u003c\/p\u003e \u003cp\u003e7.3 European Medicines Agency 236\u003c\/p\u003e \u003cp\u003e7.4 Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) 238\u003c\/p\u003e \u003cp\u003e7.5 China Food and Drug Administration 240\u003c\/p\u003e \u003cp\u003e7.6 India’s Central Drugs Standard Control Organization 240\u003c\/p\u003e \u003cp\u003e7.7 Australia’s Therapeutic Goods Administration 241\u003c\/p\u003e \u003cp\u003e7.8 Canada’s Health Canada 243\u003c\/p\u003e \u003cp\u003e7.9 Other Regulatory Authorities 243\u003c\/p\u003e \u003cp\u003e7.10 Authorities other than Drug Regulatory Agencies 243\u003c\/p\u003e \u003cp\u003e7.11 International Conference on Harmonization 244\u003c\/p\u003e \u003cp\u003e7.12 World Health Organization 245\u003c\/p\u003e \u003cp\u003e7.13 Pharmaceutical Inspection Cooperation Scheme 246\u003c\/p\u003e \u003cp\u003e7.14 Case Study # 7.1 246\u003c\/p\u003e \u003cp\u003e7.15 Case Study # 7.2 249\u003c\/p\u003e \u003cp\u003e7.16 Summary of Important Points 250\u003c\/p\u003e \u003cp\u003e7.17 Review Questions 251\u003c\/p\u003e \u003cp\u003e7.18 Brief Answers and Explanations 251\u003c\/p\u003e \u003cp\u003e7.19 Further Reading 252\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Regulatory Applications 253\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 253\u003c\/p\u003e \u003cp\u003e8.2 United States 254\u003c\/p\u003e \u003cp\u003e8.3 European Union 272\u003c\/p\u003e \u003cp\u003e8.4 Japan 280\u003c\/p\u003e \u003cp\u003e8.5 China 282\u003c\/p\u003e \u003cp\u003e8.6 India 287\u003c\/p\u003e \u003cp\u003e8.7 Australia 287\u003c\/p\u003e \u003cp\u003e8.8 Canada 287\u003c\/p\u003e \u003cp\u003e8.9 Case Study #8.1 290\u003c\/p\u003e \u003cp\u003e8.10 Case Study #8.2 292\u003c\/p\u003e \u003cp\u003e8.11 Summary of Important Points 294\u003c\/p\u003e \u003cp\u003e8.12 Review Questions 299\u003c\/p\u003e \u003cp\u003e8.13 Brief Answers and Explanations 299\u003c\/p\u003e \u003cp\u003e8.14 Further Reading 300\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Good Manufacturing Practice: Regulatory Requirements 301\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 301\u003c\/p\u003e \u003cp\u003e9.2 United States 302\u003c\/p\u003e \u003cp\u003e9.3 Europe 308\u003c\/p\u003e \u003cp\u003e9.4 International Conference on Harmonization (ICH) 309\u003c\/p\u003e \u003cp\u003e9.5 Pharmaceutical Inspection Cooperation Scheme (PIC\/S) 311\u003c\/p\u003e \u003cp\u003e9.6 Selected Core Elements of GMP 312\u003c\/p\u003e \u003cp\u003e9.7 Selected GMP Systems 335\u003c\/p\u003e \u003cp\u003e9.8 New cGMP Initiatives 350\u003c\/p\u003e \u003cp\u003e9.9 Case Study #9.1 352\u003c\/p\u003e \u003cp\u003e9.10 Case Study #9.2 358\u003c\/p\u003e \u003cp\u003e9.11 Summary of Important Points 362\u003c\/p\u003e \u003cp\u003e9.12 Review Questions 363\u003c\/p\u003e \u003cp\u003e9.13 Brief Answers and Explanations 363\u003c\/p\u003e \u003cp\u003e9.14 Further Reading 364\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Good Manufacturing Practice: Drug Manufacturing 367\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 367\u003c\/p\u003e \u003cp\u003e10.2 GMP Manufacturing 371\u003c\/p\u003e \u003cp\u003e10.3 GMP Inspection 372\u003c\/p\u003e \u003cp\u003e10.4 Manufacture of Small Molecule APIs (Chemical Synthesis Methods) 379\u003c\/p\u003e \u003cp\u003e10.5 Manufacture of Large Molecule APIs (Recombinant DNA Methods) 385\u003c\/p\u003e \u003cp\u003e10.6 Finished Dosage Forms 394\u003c\/p\u003e \u003cp\u003e10.7 Product Quality Review 398\u003c\/p\u003e \u003cp\u003e10.8 Manufacturing Variations 399\u003c\/p\u003e \u003cp\u003e10.9 Case Study #10.1 400\u003c\/p\u003e \u003cp\u003e10.10 Case Study #10.2 404\u003c\/p\u003e \u003cp\u003e10.11 Summary of Important Points 407\u003c\/p\u003e \u003cp\u003e10.12 Review Questions 408\u003c\/p\u003e \u003cp\u003e10.13 Brief Answers and Explanations 408\u003c\/p\u003e \u003cp\u003e10.14 Further Reading 408\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Future Perspectives 411\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Past Advances and Future Challenges 411\u003c\/p\u003e \u003cp\u003e11.2 Small Molecule Pharmaceutical Drugs 412\u003c\/p\u003e \u003cp\u003e11.3 Large Molecule Biopharmaceutical Drugs 414\u003c\/p\u003e \u003cp\u003e11.4 Traditional Medicine 414\u003c\/p\u003e \u003cp\u003e11.5 Personalized Medicine 419\u003c\/p\u003e \u003cp\u003e11.6 Gene Therapy 420\u003c\/p\u003e \u003cp\u003e11.7 Cloning and Stem Cells 420\u003c\/p\u003e \u003cp\u003e11.8 Old Age Diseases and Aging 423\u003c\/p\u003e \u003cp\u003e11.9 Lifestyle Drugs 423\u003c\/p\u003e \u003cp\u003e11.10 Performance-Enhancing Drugs 428\u003c\/p\u003e \u003cp\u003e11.11 Chemical and Biological Terrorism 428\u003c\/p\u003e \u003cp\u003e11.12 Transgenic Animals and Plants 432\u003c\/p\u003e \u003cp\u003e11.13 Antibiotics Drug Resistance 433\u003c\/p\u003e \u003cp\u003e11.14 Regulatory Issues 435\u003c\/p\u003e \u003cp\u003e11.15 Intellectual Property Rights and Marketing Exclusivities 437\u003c\/p\u003e \u003cp\u003e11.16 Bioethics 440\u003c\/p\u003e \u003cp\u003e11.17 Concluding Remarks 442\u003c\/p\u003e \u003cp\u003e11.18 Case Study #11.1 445\u003c\/p\u003e \u003cp\u003e11.19 Case Study #11.2 447\u003c\/p\u003e \u003cp\u003e11.20 Further Reading 449\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix 1 History of Drug Discovery and Development 451\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eA1.1 Early History of Medicine 451\u003c\/p\u003e \u003cp\u003eA1.2 Drug Discovery and Development in the Middle Ages 453\u003c\/p\u003e \u003cp\u003eA1.3 Foundation of Current Drug Discovery and Development 454\u003c\/p\u003e \u003cp\u003eA1.4 Beginnings of Modern Pharmaceutical Industry 454\u003c\/p\u003e \u003cp\u003eA1.5 Evolution of Drug Products 455\u003c\/p\u003e \u003cp\u003eA1.6 Further Reading 456\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix 2 Cells, Nucleic Acids, Genes, and Proteins 457\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eA2.1 Cells 457\u003c\/p\u003e \u003cp\u003eA2.2 Nucleic Acids 460\u003c\/p\u003e \u003cp\u003eA2.3 Genes and Proteins 462\u003c\/p\u003e \u003cp\u003eA2.4 Further Reading 468\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix 3 Selected Drugs and Their Mechanisms Of Action 469\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix 4 A DHFR Plasmid Vector 481\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix 5 Vaccine Production Methods 483\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix 6 Vaccines Approved By FDA 485\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix 7 Pharmacology\/Toxicology Review Format 489\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix 8 Examples of General Biomarkers 495\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix 9 Toxicity Grading 499\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix 10 Health Systems in Selected Countries 505\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eAcronyms 509\u003c\/p\u003e \u003cp\u003eGlossary 515\u003c\/p\u003e \u003cp\u003eIndex 519\u003c\/p\u003e","brand":"John Wiley and Sons Ltd","offers":[{"title":"Default Title","offer_id":49406944411991,"sku":"9781118907276","price":75.56,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781118907276.jpg?v=1730497643"},{"product_id":"a-practical-guide-to-managing-clinical-trials-9781138196506","title":"A Practical Guide to Managing Clinical Trials","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cstrong\u003e\u003cem\u003eA Practical Guide to Managing Clinical Trials\u003c\/em\u003e\u003c\/strong\u003e is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles\/responsibilities\/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application.\u003c\/p\u003e\u003cp\u003eUnique to this book is A View from India, a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and \u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e'\"\u003cstrong\u003e\u003cem\u003eA Practical Guide to Managing Clinical Trials\u003c\/em\u003e\u003c\/strong\u003e\" provides a good introduction to the basics of clinical research for investigators, study coordinators, and other site personnel. The clear writing makes the book a quick read.'\u003cbr\u003e – \u003cstrong\u003eNorman M. Goldfarb \u003c\/strong\u003efor \u003cem\u003eJournal of Clinical Research Best Practices\u003c\/em\u003e, Vol. 13, No. 12, December 2017.\u003c\/p\u003e\u003cbr\u003e\u003cp\u003e'\"\u003cstrong\u003e\u003cem\u003eA Practical Guide to Managing Clinical Trials\u003c\/em\u003e\u003c\/strong\u003e\" provides a good introduction to the basics of clinical research for investigators, study coordinators, and other site personnel. The clear writing makes the book a quick read.'\u003cbr\u003e – \u003cstrong\u003eNorman M. Goldfarb \u003c\/strong\u003efor \u003cem\u003eJournal of Clinical Research Best Practices\u003c\/em\u003e, Vol. 13, No. 12, December 2017.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cstrong\u003eChapter 1:\u003c\/strong\u003e Rules, Roles and Responsibilities\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eChapter 2:\u003c\/strong\u003e Products, Protocols, and Pre-trial Preparation\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eChapter 3:\u003c\/strong\u003e Sponsor, Site and Study Start-up\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eChapter 4:\u003c\/strong\u003e Enticement, Enrollment, and Engagement: The Informed Consent Process\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eChapter 5:\u003c\/strong\u003e From Enrollment to Final Visit\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eChapter 6:\u003c\/strong\u003e Collaborating for Compliance and Quality Data – Monitoring and Audits\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eChapter 7:\u003c\/strong\u003e Building Budgets\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eChapter 8:\u003c\/strong\u003e Contracts, Clauses and Closing the Deal\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eChapter 9:\u003c\/strong\u003e US Clinical Trials – Additional Topics\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eChapter 10:\u003c\/strong\u003e Clinical Research and India\u003c\/p\u003e","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":49407215010135,"sku":"9781138196506","price":87.39,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781138196506.jpg?v=1730498596"},{"product_id":"cardiovascular-clinical-trials-9781405162159","title":"Cardiovascular Clinical Trials","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eThe pace of therapeutic advances in the treatment of cardiovascular diseases is rapid, and new clinically-relevant information appears with such frequency that it can be extremely challenging for clinicians to keep up.\u003c\/p\u003e \u003cp\u003eStill, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eConfidently apply gold standard treatment for 10 of the most critical areas of cardiology\u003cbr\u003e \u003c\/b\u003e Written by an international team of experts, \u003cb\u003e\u003ci\u003eCardiovascular Clinical Trials: Putting the Evidence into Practice\u003c\/i\u003e\u003c\/b\u003e:\u003c\/p\u003e \u003cul\u003e \u003cli\u003eProvides a succinct overview of recent major clinical trials - the gold standard for all medical treatment - across all the major cardiovascular subspecialties, to ensure you're up-to-date on the most critical findings\u003c\/li\u003e \u003cli\u003eGuides cardiology trainees and clinicians on how cardiov\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e“This is an excellent contribution to the evidence-based practice of cardiovascular medicine and will be a valuable reference tool.”  (\u003ci\u003eDoody’s\u003c\/i\u003e, 14 June 2013)\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\n\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eList of Contributors viii\u003c\/p\u003e \u003cp\u003ePreface x\u003c\/p\u003e \u003cp\u003eList of Abbreviations xi\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Introduction to randomized clinical trials in cardiovascular disease 1\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eTobias Geisler, Marcus D. Flather, Deepak L. Bhatt, and Ralph B. D’Agostino, Sr\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Publishing results of clinical trials and reviewing papers for publication 44\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eTobias Geisler and Marcus D. Flather\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Management of chronic coronary artery disease 60\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eSabu Thomas and William E. Boden\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Acute coronary syndromes (ST elevation and non-ST elevation) 86\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eTobias Geisler, Deepak L. Bhatt, and Marcus D. Flather\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Heart failure 117\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eChristopher M. O’Connor and Wendy Gattis Stough\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Atrial fibrillation 143\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eChee W. Khoo and Gregory Y.H. Lip\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Electrophysiology and pacing 174\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eIrina Suman-Horduna and Sabine Ernst\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Percutaneous coronary intervention 205\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eDharam J. Kumbhani and Deepak L. Bhatt\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Randomized controlled trials in cardiac surgery: is there any alternative? 243\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eThanos Athanasiou, Amir Sepehripour, and John Pepper\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Adult congenital heart disease 274\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eCary Ward, J. Kevin Harrison, and Thomas M. Bashore\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Cardiac imaging 296\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAiden Abidov and Daniel S. Berman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Prevention of cardiovascular disease 345\u003cbr\u003e \u003c\/b\u003e\u003ci\u003eAlice J. Owen and Christopher M. Reid\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 378\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49407897829719,"sku":"9781405162159","price":62.96,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781405162159.jpg?v=1730500889"},{"product_id":"a-clinical-trials-manual-from-the-duke-clinical-research-institute-9781405195157","title":"A Clinical Trials Manual From The Duke Clinical","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eThe publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient enrolled in a trial. Those who study this manual will be well aware of how to ensure patient safety along with fiscal responsibility, trial efficiency, and research integrity.\u003cbr\u003e \u003cb\u003eRobert Harrington\u003c\/b\u003e, Professor of Medicine, Director, Duke Clinical Research Institute, Durham, North Carolina, USA  \u003cp\u003eThe Duke Clinical Research Institute (DCRI) is one of the world''s leading academic clinical research organizations; its mission is to develop and share knowledge that improves the care of patients around the world through innovative clinical research. This concise handbook provides a practical nut\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\"This is an excellent guide to how to conduct clinical trials of medical devices and biologics in the light of recent regulatory and clinical developments. The roles and responsibilities of institutional review boards and recent developments regarding subject privacy concerns and regulations are well covered. This manual also provides sample forms and worksheets for data management.\" (Doody's, 5 August 2011)  \u003c\/p\u003e\u003cp\u003e\"A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons from a Horse Named Jim, 2nd Edition\" is a good introduction to clinical research, primarily from the site perspective. The book gives readers a solid foundation of principles and knowledge.\" (Journal of Clinical Research Best Practices, 8 August 2011)\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eForeword by Robert A. Harrington xiii\u003c\/p\u003e \u003cp\u003ePreface xv\u003c\/p\u003e \u003cp\u003eList of Abbreviations xviii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Lessons from a Horse Named Jim and Other Events in History Affecting the Regulation of Clinical Research 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 The Process: Developing New Drugs, Biologics, and Devices 13\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe Drug Development Process 14\u003c\/p\u003e \u003cp\u003eBackground Information 14\u003c\/p\u003e \u003cp\u003ePre-Clinical Studies 15\u003c\/p\u003e \u003cp\u003eThe Investigational New Drug Application 16\u003c\/p\u003e \u003cp\u003eClinical Trial Phases 17\u003c\/p\u003e \u003cp\u003eApplication to Market New Drugs and Biologics 20\u003c\/p\u003e \u003cp\u003eFDA Review Groups 21\u003c\/p\u003e \u003cp\u003eEarly or Expanded Access to Unapproved Drugs and Biologics 24\u003c\/p\u003e \u003cp\u003eOrphan Drugs 25\u003c\/p\u003e \u003cp\u003eDeveloping New Devices 26\u003c\/p\u003e \u003cp\u003eBackground Information 27\u003c\/p\u003e \u003cp\u003eWhat is a Medical Device? 28\u003c\/p\u003e \u003cp\u003eMedical Device Classification 29\u003c\/p\u003e \u003cp\u003eRequirements for Marketing New Devices 33\u003c\/p\u003e \u003cp\u003eHumanitarian Use Devices 36\u003c\/p\u003e \u003cp\u003eEarly or Expanded Access to Unapproved Medical Devices 36\u003c\/p\u003e \u003cp\u003eFDA Device Review 38\u003c\/p\u003e \u003cp\u003eCombination Products 38\u003c\/p\u003e \u003cp\u003ePostmarketing Surveillance of Drugs, Biologics, and Devices 39\u003c\/p\u003e \u003cp\u003ePhase 4 Postmarketing Drug and Biologics Studies 40\u003c\/p\u003e \u003cp\u003ePhase 4 Postmarketing Device Studies 40\u003c\/p\u003e \u003cp\u003eDirect Reporting Based on Observations 41\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Good Clinical Practice and the Regulations 49\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGood Clinical Practice 50\u003c\/p\u003e \u003cp\u003eRegulations 50\u003c\/p\u003e \u003cp\u003eGuidelines 59\u003c\/p\u003e \u003cp\u003eLocal Laws 60\u003c\/p\u003e \u003cp\u003eResponsibilities in the Code of Federal Regulations 62\u003c\/p\u003e \u003cp\u003ePrincipal Investigator Responsibilities 62\u003c\/p\u003e \u003cp\u003eInstitutional Review Board Responsibilities 67\u003c\/p\u003e \u003cp\u003eSponsor Responsibilities 68\u003c\/p\u003e \u003cp\u003eSponsor-Investigators 70\u003c\/p\u003e \u003cp\u003eWhere to Obtain Information and Guidance for the Regulations and GCP 70\u003c\/p\u003e \u003cp\u003eThe Federal Register 70\u003c\/p\u003e \u003cp\u003eFDA Guidance Documents 71\u003c\/p\u003e \u003cp\u003eOnline Resources 71\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Informed Consent and the Regulations 73\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eWhat Is Informed Consent? 74\u003c\/p\u003e \u003cp\u003eEthical Codes Regarding Informed Consent 75\u003c\/p\u003e \u003cp\u003eThe Belmont Report: Application of Respect for Persons 75\u003c\/p\u003e \u003cp\u003eThe Declaration of Helsinki 76\u003c\/p\u003e \u003cp\u003eThe Nuremberg Code 77\u003c\/p\u003e \u003cp\u003eRegulatory Requirements for Informed Consent 77\u003c\/p\u003e \u003cp\u003eGeneral Requirements for Informed Consent (21 CFR 50.20) 78\u003c\/p\u003e \u003cp\u003eExceptions from the General Requirements (21 CFR 50.23) 79\u003c\/p\u003e \u003cp\u003eExceptions from Informed Consent Requirements for Emergency Research (21 CFR 50.24) 79\u003c\/p\u003e \u003cp\u003eElements of Informed Consent (21 CFR 50.25) 80\u003c\/p\u003e \u003cp\u003eDocumentation of Informed Consent (21 CFR 50.27) 82\u003c\/p\u003e \u003cp\u003eConsent from Vulnerable Subjects 85\u003c\/p\u003e \u003cp\u003eHIPAA\/Privacy Rule Requirements 90\u003c\/p\u003e \u003cp\u003eThe Informed Consent Process 92\u003c\/p\u003e \u003cp\u003eWriting the Consent Form 92\u003c\/p\u003e \u003cp\u003eObtaining Informed Consent 95\u003c\/p\u003e \u003cp\u003eDocumenting Informed Consent 96\u003c\/p\u003e \u003cp\u003eContinuing Informed Consent 97\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Institutional Review Boards 101\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eWhat is an Institutional Review Board? 102\u003c\/p\u003e \u003cp\u003eTypes of IRBs 103\u003c\/p\u003e \u003cp\u003eIRB Membership 104\u003c\/p\u003e \u003cp\u003eIRB Activities 107\u003c\/p\u003e \u003cp\u003eReviewing Research 107\u003c\/p\u003e \u003cp\u003eReporting Unanticipated Problems Involving Risks to Subjects or Others 109\u003cbr\u003e \u003cbr\u003e Establishing Written Procedures 110\u003c\/p\u003e \u003cp\u003eTypes of IRB Review 111\u003c\/p\u003e \u003cp\u003eFull Committee Review 111\u003c\/p\u003e \u003cp\u003eExpedited Review 112\u003c\/p\u003e \u003cp\u003eItems That Must be Submitted for IRB Review 113\u003c\/p\u003e \u003cp\u003eExemptions: When IRB Approval Is Not Required 113\u003c\/p\u003e \u003cp\u003eContinuing Review after Initial Study Approval 114\u003c\/p\u003e \u003cp\u003eReview of Adverse Events and Unanticipated Problems 115\u003c\/p\u003e \u003cp\u003eCommunication between IRBs and Investigators 116\u003c\/p\u003e \u003cp\u003eInvestigator Notification of the Outcome of IRB Review 116\u003c\/p\u003e \u003cp\u003eCommunication During Study 116\u003c\/p\u003e \u003cp\u003eIRB Notification at Study Completion 117\u003c\/p\u003e \u003cp\u003eCommunication between IRBs and Study Sponsors 117\u003c\/p\u003e \u003cp\u003eIRB Records and Reports 118\u003c\/p\u003e \u003cp\u003eAccreditation of IRBs 119\u003c\/p\u003e \u003cp\u003eRegistration 120\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others 123\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eWhy Collect Adverse Event Data? 124\u003c\/p\u003e \u003cp\u003eSafety Profile 125\u003c\/p\u003e \u003cp\u003eBenefits and Risks Evaluation 125\u003c\/p\u003e \u003cp\u003ePackage Insert 125\u003c\/p\u003e \u003cp\u003eAdverse Events 125\u003c\/p\u003e \u003cp\u003eInternal and External Adverse Events 126\u003c\/p\u003e \u003cp\u003eSerious Adverse Events 126\u003c\/p\u003e \u003cp\u003eUnanticipated Problems Involving Risks to Subjects or Others 127\u003c\/p\u003e \u003cp\u003eInvestigator Responsibilities 129\u003c\/p\u003e \u003cp\u003eCollecting Adverse Event Data 129\u003c\/p\u003e \u003cp\u003eReporting Adverse Event Data 130\u003c\/p\u003e \u003cp\u003eExpedited Reporting of Adverse Events 131\u003c\/p\u003e \u003cp\u003eReporting Unanticipated Problems Involving Risks to Subjects or Others 133\u003c\/p\u003e \u003cp\u003eReporting Unanticipated Adverse Device Effects 135\u003c\/p\u003e \u003cp\u003eIRB Responsibilities 135\u003c\/p\u003e \u003cp\u003eReview and Reporting of Serious Adverse Events 135\u003c\/p\u003e \u003cp\u003eReview and Reporting of Unanticipated Problems 136\u003c\/p\u003e \u003cp\u003eSponsor Responsibilities 136\u003c\/p\u003e \u003cp\u003eExpedited Reporting in Drug Trials 137\u003c\/p\u003e \u003cp\u003eExpedited Reporting in Device Trials 138\u003c\/p\u003e \u003cp\u003eRoutine Reporting by Sponsors 139\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Monitoring, Audits, and Inspections 141\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eMonitoring Plan 143\u003c\/p\u003e \u003cp\u003eOn-Site Monitoring 144\u003c\/p\u003e \u003cp\u003eTypes of On-Site Monitoring Visits 145\u003c\/p\u003e \u003cp\u003eDocumenting Monitoring Visits 151\u003c\/p\u003e \u003cp\u003eIn-House Monitoring 152\u003c\/p\u003e \u003cp\u003eComputerized Checks 153\u003c\/p\u003e \u003cp\u003eSource Document Verification Done at the Sponsor or Data Center 153\u003c\/p\u003e \u003cp\u003eProtected Health Information 154\u003c\/p\u003e \u003cp\u003eAudits and Inspections 154\u003c\/p\u003e \u003cp\u003eAudits and Inspections in the Regulations and Guidelines 155\u003c\/p\u003e \u003cp\u003eSponsor Quality Assurance Audits 156\u003c\/p\u003e \u003cp\u003eFDA Inspections 157\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 The Principal Investigator, the Clinical Research Coordinator, and the Study Site 163\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eThe Principal Investigator 164\u003c\/p\u003e \u003cp\u003eCharacteristics of an Effective Principal Investigator 165\u003c\/p\u003e \u003cp\u003eConflict of Interest 167\u003c\/p\u003e \u003cp\u003eInvestigator Delegation of Study Activities 169\u003c\/p\u003e \u003cp\u003eStaffing to Support Clinical Trials 169\u003c\/p\u003e \u003cp\u003eClinical Research Coordinator 169\u003c\/p\u003e \u003cp\u003eSubinvestigators 172\u003c\/p\u003e \u003cp\u003eSupport Personnel 173\u003c\/p\u003e \u003cp\u003eSpace and Resource Needs 173\u003c\/p\u003e \u003cp\u003eWorkspace for the Clinical Research Coordinator 173\u003c\/p\u003e \u003cp\u003eEquipment 174\u003c\/p\u003e \u003cp\u003eStorage Space 174\u003c\/p\u003e \u003cp\u003eAdditional Space 175\u003c\/p\u003e \u003cp\u003eThe Local Institutional Review Board 175\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 The Protocol 177\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eCommon Components of a Protocol 180\u003c\/p\u003e \u003cp\u003eBackground and Rationale 180\u003c\/p\u003e \u003cp\u003eStudy Organization 180\u003c\/p\u003e \u003cp\u003eObjectives\/Endpoints 181\u003c\/p\u003e \u003cp\u003eQuality of Life Parameters 181\u003c\/p\u003e \u003cp\u003eEconomic Factors 182\u003c\/p\u003e \u003cp\u003eSurrogate Endpoints 182\u003c\/p\u003e \u003cp\u003eStudy Design 183\u003c\/p\u003e \u003cp\u003eUse of Control Groups 184\u003c\/p\u003e \u003cp\u003eRandomization 185\u003c\/p\u003e \u003cp\u003eBlinding 187\u003c\/p\u003e \u003cp\u003eObservational Studies 188\u003c\/p\u003e \u003cp\u003eStudy Population 190\u003c\/p\u003e \u003cp\u003eStudy Treatment Plan 191\u003c\/p\u003e \u003cp\u003eSafety Assessment, Management, and Reporting 192\u003c\/p\u003e \u003cp\u003eReplacement of Withdrawn, Dropped Out, and Lost to Follow-up Subjects 193\u003c\/p\u003e \u003cp\u003eStatistical Aspects 193\u003c\/p\u003e \u003cp\u003ePower 193\u003c\/p\u003e \u003cp\u003eSample Size 193\u003c\/p\u003e \u003cp\u003eIntention-to-treat Principle 194\u003c\/p\u003e \u003cp\u003eInterim Analysis 195\u003c\/p\u003e \u003cp\u003eData and Safety Monitoring Board 196\u003c\/p\u003e \u003cp\u003eSubject Data and Record Retention 197\u003c\/p\u003e \u003cp\u003eMonitoring 197\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Study Feasibility: Reviewing a Specific Protocol 199\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eReviewing a Specific Protocol 200\u003c\/p\u003e \u003cp\u003eStudy Design 200\u003c\/p\u003e \u003cp\u003eResearch Subject Population 201\u003c\/p\u003e \u003cp\u003eInvestigator Time Requirements 202\u003c\/p\u003e \u003cp\u003eClinical Research Coordinator and Other Study Personnel 202\u003c\/p\u003e \u003cp\u003eLaboratory Tests and Procedures 204\u003c\/p\u003e \u003cp\u003eAdditional Space and Equipment 205\u003c\/p\u003e \u003cp\u003eBudget Considerations 206\u003c\/p\u003e \u003cp\u003ePreparing a Budget 207\u003c\/p\u003e \u003cp\u003eBudget Planning 209\u003c\/p\u003e \u003cp\u003eNegotiating a Budget 211\u003c\/p\u003e \u003cp\u003eShould We Do this Study at Our Site? 211\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Study Activities 213\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eStudy Start-up Phase 215\u003c\/p\u003e \u003cp\u003eReview the Protocol, Develop a Budget, Prepare Documents for IRB Submission 215\u003c\/p\u003e \u003cp\u003eEstablish the Site Study Team 216\u003c\/p\u003e \u003cp\u003eParticipate in Investigator Meetings 219\u003c\/p\u003e \u003cp\u003eDevelop a Recruitment and Enrollment Plan 219\u003c\/p\u003e \u003cp\u003eConduct Education and Training Sessions for Site Personnel 228\u003c\/p\u003e \u003cp\u003eBegin Randomization and Enrollment of Subjects 230\u003c\/p\u003e \u003cp\u003eStudy Maintenance Phase 230\u003c\/p\u003e \u003cp\u003eComplete Data Forms 231\u003c\/p\u003e \u003cp\u003eReport Serious Adverse Events (SAE) and Unanticipated Problems 231\u003c\/p\u003e \u003cp\u003eConduct Subject Follow-up Visits 231\u003c\/p\u003e \u003cp\u003eEnsure Subject Retention and Compliance 233\u003c\/p\u003e \u003cp\u003eUnblind Study Treatment Only When Required 238\u003c\/p\u003e \u003cp\u003eMaintain Study Drug\/Device Accountability 239\u003c\/p\u003e \u003cp\u003eManage Specimens, Samples, and Other Study-related Materials 239\u003c\/p\u003e \u003cp\u003eObtain Answers to Urgent Clinical Questions 239\u003c\/p\u003e \u003cp\u003eContinue Communication 239\u003c\/p\u003e \u003cp\u003eMaintain Study File 240\u003c\/p\u003e \u003cp\u003eStudy Completion and Close-Out Phase 240\u003c\/p\u003e \u003cp\u003eCompletion of All Subject Data Forms and Resolution of Data Queries 241\u003c\/p\u003e \u003cp\u003eDestruction or Return of Study Materials 241\u003c\/p\u003e \u003cp\u003eReview of Site Study File 241\u003c\/p\u003e \u003cp\u003eSubmission of the Final Report 241\u003c\/p\u003e \u003cp\u003eLong-term Storage of Study Records 242\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Study Documents\/Essential Documents 245\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eDocuments at Study Start-Up 246\u003c\/p\u003e \u003cp\u003eConfidentiality Agreement 247\u003c\/p\u003e \u003cp\u003eSigned Protocol and Applicable Amendments 247\u003c\/p\u003e \u003cp\u003eLetter of Agreement 247\u003c\/p\u003e \u003cp\u003eInvestigator’s Brochure 248\u003c\/p\u003e \u003cp\u003eCurriculum Vitae (CV)\/Statement of Investigator Qualifications 248\u003c\/p\u003e \u003cp\u003eMedical Licensure Form 248\u003c\/p\u003e \u003cp\u003eForm FDA 1572 248\u003c\/p\u003e \u003cp\u003eFinancial Disclosure Information 250\u003c\/p\u003e \u003cp\u003eIRB Approval 250\u003c\/p\u003e \u003cp\u003eIRB-Approved Consent Form 252\u003c\/p\u003e \u003cp\u003eRB-Approved Advertisements and Subject Materials 253\u003c\/p\u003e \u003cp\u003eLaboratory Certification and Normal Ranges Form 253\u003c\/p\u003e \u003cp\u003eSite Demographics Form 255\u003c\/p\u003e \u003cp\u003eStudy Personnel CVs\/Résumés and Training Records 255\u003c\/p\u003e \u003cp\u003eContractual Agreement\/Financial Contract 255\u003c\/p\u003e \u003cp\u003eDocuments While the Study is in Progress 256\u003c\/p\u003e \u003cp\u003eProtocol Amendments and IRB Approval 256\u003c\/p\u003e \u003cp\u003eRevised Consent Forms and IRB Approval 257\u003c\/p\u003e \u003cp\u003eUpdated Form FDA 1572 257\u003c\/p\u003e \u003cp\u003eCVs for New PIs and Subinvestigators 257\u003cbr\u003e \u003cbr\u003e Updated Laboratory Certification and Normal Ranges Form 258\u003c\/p\u003e \u003cp\u003eIRB Correspondence 258\u003c\/p\u003e \u003cp\u003eSubject Recruitment Advertisements and Educational Materials 258\u003c\/p\u003e \u003cp\u003eScreening Log 258\u003c\/p\u003e \u003cp\u003eConfidential Master Subject Log 259\u003c\/p\u003e \u003cp\u003eSigned Consent Forms for All Enrolled Subjects 259\u003c\/p\u003e \u003cp\u003eTest Article Accountability Forms 259\u003c\/p\u003e \u003cp\u003eSerious and Reportable Adverse Event Forms 259\u003c\/p\u003e \u003cp\u003eSubject Data Forms and Query Forms 261\u003c\/p\u003e \u003cp\u003eSource Documents 261\u003c\/p\u003e \u003cp\u003eSignature and Delegation Log 263\u003c\/p\u003e \u003cp\u003eSite Visit Log 263\u003c\/p\u003e \u003cp\u003eWritten Communication and Correspondence 263\u003c\/p\u003e \u003cp\u003eDocuments at Study Close-out 263\u003c\/p\u003e \u003cp\u003eOutstanding Data Forms and Query Forms 264\u003c\/p\u003e \u003cp\u003eComplete Sets of All Subject Data Forms 264\u003c\/p\u003e \u003cp\u003eFinal Reports 264\u003c\/p\u003e \u003cp\u003eTest Article Accountability Records 264\u003c\/p\u003e \u003cp\u003eMaintaining Your Site Study File 266\u003c\/p\u003e \u003cp\u003eRecord Retention 266\u003c\/p\u003e \u003cp\u003ePrincipal Investigator Status Change 267\u003c\/p\u003e \u003cp\u003eFinal Financial Disclosure Report 267\u003c\/p\u003e \u003cp\u003eSample Study File Organization 267\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Management of Study Drugs, Biologics, and Devices 271\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eStudy Drugs and Biologics 272\u003c\/p\u003e \u003cp\u003eStudy Drug Accountability 272\u003c\/p\u003e \u003cp\u003eStudy Drug Packaging 273\u003c\/p\u003e \u003cp\u003eStudy Drug Receipt 274\u003c\/p\u003e \u003cp\u003eStudy Drug Storage 274\u003c\/p\u003e \u003cp\u003eDispensing Study Drug 274\u003c\/p\u003e \u003cp\u003eStudy Drug Unblinding 277\u003c\/p\u003e \u003cp\u003eFinal Disposition of Study Drug 278\u003c\/p\u003e \u003cp\u003eStudy Devices 278\u003c\/p\u003e \u003cp\u003eDevice Labeling 278\u003c\/p\u003e \u003cp\u003eDevice Accountability 279\u003c\/p\u003e \u003cp\u003eDevice Tracking 279\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Managing Clinical Trial Data 281\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eHIPAA, the Privacy Rule, and Clinical Trial Data 282\u003c\/p\u003e \u003cp\u003eUse of Protected Health Information With Individual Authorization 283\u003c\/p\u003e \u003cp\u003eUse of Protected Health Information Without Individual Authorization 283\u003c\/p\u003e \u003cp\u003eSubject Identifiers 284\u003c\/p\u003e \u003cp\u003eGuidelines and Regulations Regarding Clinical Trial Data 284\u003c\/p\u003e \u003cp\u003eICH E6 Section 2: The Principles of ICH GCP 284\u003c\/p\u003e \u003cp\u003eICH E6 Section 4: Records and Reports 285\u003c\/p\u003e \u003cp\u003e21 CFR 312 and §812 285\u003c\/p\u003e \u003cp\u003eElectronic Data 285\u003c\/p\u003e \u003cp\u003eStudy Site Responsibilities Regarding Clinical Trial Data 287\u003c\/p\u003e \u003cp\u003eRecord the Data in Source Documents 287\u003c\/p\u003e \u003cp\u003eComplete Data Forms 290\u003c\/p\u003e \u003cp\u003eCorrect the Data 302\u003c\/p\u003e \u003cp\u003eSubmit the Data 307\u003c\/p\u003e \u003cp\u003eStore\/Archive the Data 308\u003c\/p\u003e \u003cp\u003eSource Document Verification of Clinical Trial Data 308\u003c\/p\u003e \u003cp\u003eRelease of Protected Medical Information 309\u003c\/p\u003e \u003cp\u003eConfidentiality of Clinical Trial Data 310\u003c\/p\u003e \u003cp\u003eEndpoint Adjudication 310\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Global Health and International Trials 313\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eInternational Clinical Trials 314\u003c\/p\u003e \u003cp\u003eEthnic and Racial Differences 315\u003c\/p\u003e \u003cp\u003eEthical Issues and Cultural Sensitivities 316\u003c\/p\u003e \u003cp\u003eWhy International Trials Are Important 317\u003c\/p\u003e \u003cp\u003eHIV\/AIDS 318\u003c\/p\u003e \u003cp\u003eMalaria 318\u003c\/p\u003e \u003cp\u003eTuberculosis 318\u003c\/p\u003e \u003cp\u003ePolio 319\u003c\/p\u003e \u003cp\u003eInternational Regulations 320\u003c\/p\u003e \u003cp\u003eConcerns 321\u003c\/p\u003e \u003cp\u003eFuture Efforts 322\u003c\/p\u003e \u003cp\u003eAppendices 325\u003c\/p\u003e \u003cp\u003eAppendix A 327\u003c\/p\u003e \u003cp\u003eAppendix B 342\u003c\/p\u003e \u003cp\u003eAppendix C 355\u003c\/p\u003e \u003cp\u003eAppendix D 362\u003c\/p\u003e \u003cp\u003eAppendix E 370\u003c\/p\u003e \u003cp\u003eEpilogue by Lisa G. Berdan 379\u003c\/p\u003e \u003cp\u003eGlossary 382\u003c\/p\u003e \u003cp\u003eIndex 395\u003c\/p\u003e","brand":"John Wiley and Sons Ltd","offers":[{"title":"Default Title","offer_id":49407928435031,"sku":"9781405195157","price":999.99,"currency_code":"GBP","in_stock":false}]},{"product_id":"clinical-research-and-the-law-9781405195676","title":"Clinical Research and the Law","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eThis book provides a comprehensive resource for medical professionals on the various legal aspects involved in conducting clinical research.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e “Clinical Research and the Law” provides thoughtful and practical information on a broad range of legal topics related to clinical research, with an emphasis on subject injury liability. The book is useful for anyone who is not an expert in a particular area of law, with numerous citations for further investigation.”  (\u003ci\u003eJournal of Clinical Research Best Practices\u003c\/i\u003e, 1 October 2012)\u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e \u003cp\u003e \u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePreface, ix\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 1: Research malpractice and negligence, 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Background, 1\u003c\/p\u003e \u003cp\u003e1.2 Drugs: brief description of definitions, 4\u003c\/p\u003e \u003cp\u003e1.3 Brief overview: conduct of clinical trials, 5\u003c\/p\u003e \u003cp\u003e1.4 Medical devices, 6\u003c\/p\u003e \u003cp\u003e1.5 Research malpractice: the basics, 7\u003c\/p\u003e \u003cp\u003e1.6 Negligence actions and research: interesting aspects of medical research negligence cases, 8\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 2: Duty of care: understanding the legal differences between medical treatment and medical research, 23\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Establishing duty of care, 23\u003c\/p\u003e \u003cp\u003e2.2 Do sponsors have a legal duty?, 27\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 3: Establishing standard of care and violation of standard of care, 33\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Research malpractice and using expert testimony to establish the standard of care, 34\u003c\/p\u003e \u003cp\u003e3.2 Lessons learned from surgical innovation cases, 35\u003c\/p\u003e \u003cp\u003e3.3 Standard of care and informed consent cases, 36\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 4: Informed consent in clinical research, 37\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Basics on informed consent in the clinical treatment setting: background, 37\u003c\/p\u003e \u003cp\u003e4.2 Informed consent as applied to the research setting, 40\u003c\/p\u003e \u003cp\u003e4.3 Informed consent and federal regulations, 42\u003c\/p\u003e \u003cp\u003e4.4 Case law and federal regulations, 43\u003c\/p\u003e \u003cp\u003e4.5 Clinical trials and pediatric patients, 46\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 5: Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs), 55\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Liability for negligence, 56\u003c\/p\u003e \u003cp\u003e5.2 Standard of care, 57\u003c\/p\u003e \u003cp\u003e5.3 Proximate cause and damages, 59\u003c\/p\u003e \u003cp\u003e5.4 Defense, 60\u003c\/p\u003e \u003cp\u003e5.5 Practical considerations: the need for indemnification, 62\u003c\/p\u003e \u003cp\u003e5.6 Special considerations for DSMBs, 62\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 6: Legal aspects of financial conflicts of interest in clinical trials, 65\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Overview, 66\u003c\/p\u003e \u003cp\u003e6.2 Legislative background: road to creating financial conflicts of interest, 68\u003c\/p\u003e \u003cp\u003e6.3 Financial conflicts of interest: evidence that financial conflicts of interest are problematic, 69\u003c\/p\u003e \u003cp\u003e6.4 Regulations\/legislation, 70\u003c\/p\u003e \u003cp\u003e6.5 Litigation involving financial conflicts of interest in clinical trials, 74\u003c\/p\u003e \u003cp\u003e6.6 Applying novel legal theories to financial conflicts of interest cases, 79\u003c\/p\u003e \u003cp\u003e6.7 Other clinical trial cases involving financial conflicts of interest claiming constitutional violations, 81\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 7: Disclosure of clinical trial information: legal ramifications of withholding study results, 87\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 GlaxoSmithKline, 89\u003c\/p\u003e \u003cp\u003e7.2 Vioxx and Merck, 91\u003c\/p\u003e \u003cp\u003e7.3 Government and other clinical trial disclosure requirements, 97\u003c\/p\u003e \u003cp\u003e7.4 Medical journal editors and disclosure of clinical trial information, 98\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 8: Clinical trials and insider trading, 105\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Purpose of insider trading laws, 105\u003c\/p\u003e \u003cp\u003e8.2 Proving insider trading, 106\u003c\/p\u003e \u003cp\u003e8.3 Penalties, 108\u003c\/p\u003e \u003cp\u003e8.4 Insider trading cases and clinical trials, 108\u003c\/p\u003e \u003cp\u003e8.5 Beware: investigators and relationships with the investment industry—a risk of recent vintage, 111\u003c\/p\u003e \u003cp\u003e8.6 Setting the stage, 113\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 9: Clinical trials and criminal law, 117\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 How clinical trial investigators have been implicated in criminal acts, 119\u003c\/p\u003e \u003cp\u003e9.2 False Claims Act cases and health-care fraud, 120\u003c\/p\u003e \u003cp\u003e9.3 Clinical trial False Claims Act cases, 122\u003c\/p\u003e \u003cp\u003e9.4 Enforcement of the False Claims Act against institutions, 130\u003c\/p\u003e \u003cp\u003e9.5 Anti-kickback law, 132\u003c\/p\u003e \u003cp\u003e9.6 Health-care fraud, 138\u003c\/p\u003e \u003cp\u003e9.7 Mail and wire fraud\/making false statements to government officials, 141\u003c\/p\u003e \u003cp\u003e9.8 Proposed new FDA rule, 143\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 10: Clinical trial contracts, 145\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Key terms\/scope of study, 146\u003c\/p\u003e \u003cp\u003e10.2 Costs\/payments, 147\u003c\/p\u003e \u003cp\u003e10.3 Data, 147\u003c\/p\u003e \u003cp\u003e10.4 Intellectual property, 148\u003c\/p\u003e \u003cp\u003e10.5 Indemnification\/injuries, 148\u003c\/p\u003e \u003cp\u003e10.6 Publications, 149\u003c\/p\u003e \u003cp\u003e10.7 Various sundry provisions, 149\u003c\/p\u003e \u003cp\u003eAppendix A: Glossary of common terms used in connection with clinical trials, 151\u003c\/p\u003e \u003cp\u003eAppendix B: Research involving human subjects, 163\u003c\/p\u003e \u003cp\u003eAppendix C: Best pharmaceuticals for Children Act, 173\u003c\/p\u003e \u003cp\u003eAppendix D: Pediatric research Equity Act of 2003, 193\u003c\/p\u003e \u003cp\u003eAppendix E: Title 21–food and drugs: additional safeguards for children in clinical investigations, 203\u003c\/p\u003e \u003cp\u003eAppendix F: Proposed standardized\/harmonized clauses for clinical trial agreements, 209\u003c\/p\u003e \u003cp\u003eAppendix G: Responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors, 225\u003c\/p\u003e \u003cp\u003eIndex, 257\u003c\/p\u003e","brand":"John Wiley and Sons Ltd","offers":[{"title":"Default Title","offer_id":49407928861015,"sku":"9781405195676","price":56.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781405195676.jpg?v=1730500989"},{"product_id":"how-to-write-a-grant-application-9781405197557","title":"How to Write a Grant Application","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eHealthcare professionals who want to increase their chances of approval can depend on the practical advice found in this book by a highly experienced clinical trialist author. Providing a concise and easy-to-read overview,  How to Write a Grant Application includes pointers on what to include and what to avoid.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\"Intended for those who are preparing to apply for a clinical grant, this guide covers this complex process in an accessible manner.\" (\u003ci\u003eBooknews\u003c\/i\u003e, 1 April 2011)\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003eForeword.  \u003cp\u003ePreface.\u003c\/p\u003e \u003cp\u003eAcknowledgements.\u003c\/p\u003e \u003cp\u003eAbout the author.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 1: Overview.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Types of grants.\u003c\/p\u003e \u003cp\u003e1.2 Types of funding organisations.\u003c\/p\u003e \u003cp\u003e1.3 Choosing an appropriate funding body.\u003c\/p\u003e \u003cp\u003e1.4 Contents of the grant application.\u003c\/p\u003e \u003cp\u003e1.5 Including several studies in one application (project grants).\u003c\/p\u003e \u003cp\u003e1.6 Translational research sub-studies.\u003c\/p\u003e \u003cp\u003e1.7 The application process.\u003c\/p\u003e \u003cp\u003e1.8 Estimating timelines and a planned work schedule.\u003c\/p\u003e \u003cp\u003e1.9 Intellectual property.\u003c\/p\u003e \u003cp\u003e1.10 Text, grammar and format.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 2: People involved in the study.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Who should be part of the Study Team?\u003c\/p\u003e \u003cp\u003e2.2 Other investigators, collaborators and consultants.\u003c\/p\u003e \u003cp\u003e2.3 The host institution and Sponsor.\u003c\/p\u003e \u003cp\u003e2.4 Commercial companies.\u003c\/p\u003e \u003cp\u003e2.5 Oversight committees.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 3: Justifi cation for the study.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Finding background information.\u003c\/p\u003e \u003cp\u003e3.2 Previous evidence and similar research (why the study is needed now).\u003c\/p\u003e \u003cp\u003e3.3 Biological plausibility.\u003c\/p\u003e \u003cp\u003e3.4 Safety of new interventions in clinical trials.\u003c\/p\u003e \u003cp\u003e3.5 Feasibility.\u003c\/p\u003e \u003cp\u003e3.6 What will the study contribute?\u003c\/p\u003e \u003cp\u003e3.7 Summary of the justifi cation for a proposed study.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 4: Describing the study design.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Abstract.\u003c\/p\u003e \u003cp\u003e4.2 Appendices.\u003c\/p\u003e \u003cp\u003e4.3 Study objectives and outcome measures.\u003c\/p\u003e \u003cp\u003e4.4 Types of studies.\u003c\/p\u003e \u003cp\u003e4.5 Observational studies in humans.\u003c\/p\u003e \u003cp\u003e4.6 Clinical trials in humans.\u003c\/p\u003e \u003cp\u003e4.7 Laboratory experiments.\u003c\/p\u003e \u003cp\u003e4.8 Describing sample size.\u003c\/p\u003e \u003cp\u003e4.9 Describing the main statistical analyses.\u003c\/p\u003e \u003cp\u003e4.10 Systematic reviews.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 5: Associated documents with the grant application.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Study protocol.\u003c\/p\u003e \u003cp\u003e5.2 Participant Information Sheet.\u003c\/p\u003e \u003cp\u003e5.3 Curricula vitae of the Chief Investigator and all co-applicants.\u003c\/p\u003e \u003cp\u003e5.4 Letters of support from co-applicants, centre investigators, collaborators, or other advisors.\u003c\/p\u003e \u003cp\u003e5.5 Letters of support from commercial companies.\u003c\/p\u003e \u003cp\u003e5.6 Other documents specifi c to the fi eld of research.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 6: Financial costs.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Overview of items to include in the fi nancial costs.\u003c\/p\u003e \u003cp\u003e6.2 Indirect costs or overheads (full economic costs).\u003c\/p\u003e \u003cp\u003e6.3 Per patient (or per subject) payments.\u003c\/p\u003e \u003cp\u003e6.4 Staff costs.\u003c\/p\u003e \u003cp\u003e6.5 Access to core funds and resources.\u003c\/p\u003e \u003cp\u003e6.6 Consideration of costs not to be met by the funding body.\u003c\/p\u003e \u003cp\u003e6.7 Grant applications associated with calls for proposals.\u003c\/p\u003e \u003cp\u003e6.8 Observational studies in humans.\u003c\/p\u003e \u003cp\u003e6.9 Clinical trials in humans.\u003c\/p\u003e \u003cp\u003e6.10 Laboratory experiments.\u003c\/p\u003e \u003cp\u003e6.11 Systematic reviews.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 7: Funding body review process.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Submitting the application.\u003c\/p\u003e \u003cp\u003e7.2 Processing the application within the funding body.\u003c\/p\u003e \u003cp\u003e7.3 Initial reviews (external reviewers).\u003c\/p\u003e \u003cp\u003e7.4 Funding committee meeting.\u003c\/p\u003e \u003cp\u003e7.5 Funding committee evaluation.\u003c\/p\u003e \u003cp\u003e7.6 Feedback to applicants after the meeting.\u003c\/p\u003e \u003cp\u003e7.7 Responding to the funding committee feedback.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eChapter 8: Annual reports and applying for a grant extension.\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Annual reports.\u003c\/p\u003e \u003cp\u003e8.2 Applying for a grant extension.\u003c\/p\u003e \u003cp\u003eBibliography.\u003c\/p\u003e \u003cp\u003eIndex.\u003c\/p\u003e","brand":"John Wiley and Sons Ltd","offers":[{"title":"Default Title","offer_id":49407930499415,"sku":"9781405197557","price":24.65,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781405197557.jpg?v=1730500993"},{"product_id":"clinical-trial-biostatistics-and-biopharmaceutical-applications-9781482212181","title":"Clinical Trial Biostatistics and","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eSince 1945, The Annual Deming Conference on Applied Statistics has been an important event in the statistics profession. In \u003cstrong\u003eClinical Trial Biostatistics and Biopharmaceutical Applications\u003c\/strong\u003e, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eDivided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT\/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical tri\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e\"This book of timely, self-contained chapters covers a wide range of current methods and unresolved challenges in clinical trial statistical methods and will prove to be an essential guide for biostatisticians who work in this field.\"\u003cbr\u003e—Dirk F. Moore, \u003cem\u003eJournal of Biopharmaceutical Statistics\u003c\/em\u003e\u003c\/p\u003e\u003cp\u003e\". . . the contributed chapters in this collection are clearly written, easily digestible, and well-referenced. The book is a useful resource for the clinical trialist interested in obtaining a quick overview of standard practices and current methodological development for a specific biostatistical application, or a worthwhile read for the researcher seeking to familiarize him or herself with a diversity of emerging topics in clinical trials.\u003cbr\u003e—Megan T. Smith, \u003ci\u003eUniversity of California, Irvine\u003c\/i\u003e\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eEmerging Issues in Clinical Trial Design and Analysis. Adaptive Clinical Trials. Clinical Trials in Oncology. Multiple Comparisons in Clinical Trials. Clinical Trials in the Genomic Era. Index.\u003c\/p\u003e","brand":"Taylor \u0026 Francis Inc","offers":[{"title":"Default Title","offer_id":49409108738391,"sku":"9781482212181","price":114.0,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781482212181.jpg?v=1730505469"},{"product_id":"data-and-safety-monitoring-committees-in-clinical-trials-9781498784108","title":"Data and Safety Monitoring Committees in Clinical","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePraise for the first edition:\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003ci\u003e\u003c\/i\u003e\u003cp\u003eGiven the author's years of experience as a statistician and as a founder of the first DMC in pharmaceutical industry trials, I highly recommend this booknot only for experts because of its cogent and organized presentation, but more importantly for young investigators who are seeking information about the logistical and philosophical aspects of a DMC. \u003c\/p\u003e\u003cp\u003e-S. T. Ounpraseuth, \u003ci\u003eThe American Statistician \u003c\/i\u003e\u003c\/p\u003e\u003cb\u003e\u003c\/b\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e \u003c\/p\u003e\u003cp\u003eIn the first edition of this well-regarded book, the author provided a groundbreaking and definitive guide to best practices in pharmaceutical industry data monitoring committees (DMCs). Maintaining all the material from the first edition and adding substantial new material, \u003cb\u003eData and Safety Monitoring Committees in Clinical Trials, Second Edition\u003c\/b\u003e is ideal for training professionals to serve on their first DMC as well as for experienced clinical and biostatistical DMC members, sponsor and reg\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003e \"The book by Dr. Herson is written amazingly well. The book concentrates on pharmaceutical industrysponsored confirmatory clinical trials and can serve as excellent sources of knowledge for all the aspects of data safety monitoring committee (DMC) activities. A great feature of the book is the “DMCounselor” section at the end of each chapter, covering nearly 70 questions with answers, of which about 33% are for a DMC Chair, 30% for the DMC Biostatistician member, 30% for a DMC physician member, and the rest are for others (e.g., project manager).\"\u003cbr\u003e\u003cem\u003e~ Daniel Jia, Journal of Biopharmaceutical Statistics\u003c\/em\u003e\u003c\/p\u003e\u003cp\u003e\"Nicely written and readable cover-to-cover, the author walks through every facet of a Data Monitoring Committee (DMC) beginning with an overview of their past and current place in drug development, to how they are organized and interfaced with other committees, and on to the specifics of how a typical meeting is split into an open and closed session. From there it moves on to clinical issues, including how SAEs are categorized, statistical methods, including Bayesian and frequentist conditional power calculations, common biases and pitfalls, and guidance for how DMC decisions are made. It concludes with emerging issues due to new clinical trial designs mandated by the FDA to speed up the drug development process.\"\u003cbr\u003e\u003cem\u003e~Donna Pauler Ankerst, Biometrics\u003c\/em\u003e\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePreface to the Second Edition. Introduction. Organization of a Safety Monitoring Program for a Confirmatory Trial. Meetings. Clinical Issues. Statistical Issues. Biases and Pitfalls. DMC Decisions. Emerging issues. Appendix.\u003c\/p\u003e","brand":"Taylor \u0026 Francis Inc","offers":[{"title":"Default Title","offer_id":49409297383767,"sku":"9781498784108","price":104.5,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781498784108.jpg?v=1730506327"},{"product_id":"crossover-designs-9781119114680","title":"Crossover Designs","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cb\u003eA comprehensive and practical resource for analyses of crossover designs\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eFor ethical reasons, it isvital to keep the number of patients in a clinical trial aslow as possible.As evidenced by extensive research publications, crossover designcan bea useful and powerfultool to reduce the number of patients needed for a parallel group design in studying treatmentsfor non-curable chronic diseases.\u003c\/p\u003e \u003cp\u003eThis book introduces commonly-used and well-established statistical tests and estimators in epidemiology that can easily be applied to hypothesis testing and estimation of the relative treatment effect for various types of data scale in crossover designs. Models with distribution-free random effects are assumed and hence most approaches considered here are semi-parametric. The book provides clinicians and biostatisticians with the exact test procedures and exact interval estimators, which are applicable even when the number of patients in a crossover trial is small. Systemat\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003eAbout the author xi\u003c\/p\u003e \u003cp\u003ePreface xii\u003c\/p\u003e \u003cp\u003eAbout the companion website xiv\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Crossover design – definitions, notes, and limitations 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Unsuitability for acute or most infectious diseases 2\u003c\/p\u003e \u003cp\u003e1.2 Inappropriateness for treatments with long-lasting effects 2\u003c\/p\u003e \u003cp\u003e1.3 Loss of efficiency in the presence of carry-over effects 3\u003c\/p\u003e \u003cp\u003e1.4 Concerns of treatment-by-period interaction 3\u003c\/p\u003e \u003cp\u003e1.5 Flaw of the commonly used two-stage test procedure 4\u003c\/p\u003e \u003cp\u003e1.6 Higher risk of dropping out or being lost to follow-up 4\u003c\/p\u003e \u003cp\u003e1.7 More assumptions needed in use of a crossover design 5\u003c\/p\u003e \u003cp\u003e1.8 General principle and conditional approach used in the book 5\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 AB\/BA design in continuous data 7\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Testing non-equality of treatments 10\u003c\/p\u003e \u003cp\u003e2.2 Testing non-inferiority of an experimental treatment to an active control treatment 11\u003c\/p\u003e \u003cp\u003e2.3 Testing equivalence between an experimental treatment and an active control treatment 12\u003c\/p\u003e \u003cp\u003e2.4 Interval estimation of the mean difference 13\u003c\/p\u003e \u003cp\u003e2.5 Sample size determination 16\u003c\/p\u003e \u003cp\u003e2.5.1 Sample size for testing non-equality 16\u003c\/p\u003e \u003cp\u003e2.5.2 Sample size for testing non-inferiority 17\u003c\/p\u003e \u003cp\u003e2.5.3 Sample size for testing equivalence 18\u003c\/p\u003e \u003cp\u003e2.6 Hypothesis testing and estimation for the period effect 19\u003c\/p\u003e \u003cp\u003e2.7 Estimation of the relative treatment effect in the presence of differential carry-over effects 21\u003c\/p\u003e \u003cp\u003e2.8 Examples of SAS programs and results 22\u003c\/p\u003e \u003cp\u003eExercises 27\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 AB\/BA design in dichotomous data 30\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Testing non-equality of treatments 34\u003c\/p\u003e \u003cp\u003e3.2 Testing non-inferiority of an experimental treatment to an active control treatment 36\u003c\/p\u003e \u003cp\u003e3.3 Testing equivalence between an experimental treatment and an active control treatment 39\u003c\/p\u003e \u003cp\u003e3.4 Interval estimation of the odds ratio 40\u003c\/p\u003e \u003cp\u003e3.5 Sample size determination 42\u003c\/p\u003e \u003cp\u003e3.5.1 Sample size for testing non-equality 42\u003c\/p\u003e \u003cp\u003e3.5.2 Sample size for testing non-inferiority 42\u003c\/p\u003e \u003cp\u003e3.5.3 Sample size for testing equivalence 43\u003c\/p\u003e \u003cp\u003e3.6 Hypothesis testing and estimation for the period effect 45\u003c\/p\u003e \u003cp\u003e3.7 Testing and estimation for carry-over effects 47\u003c\/p\u003e \u003cp\u003e3.8 SAS program codes and likelihood-based approach 48\u003c\/p\u003e \u003cp\u003eExercises 51\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 AB\/BA design in ordinal data 57\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Testing non-equality of treatments 62\u003c\/p\u003e \u003cp\u003e4.2 Testing non-inferiority of an experimental treatment to an active control treatment 64\u003c\/p\u003e \u003cp\u003e4.3 Testing equivalence between an experimental treatment and an active control treatment 65\u003c\/p\u003e \u003cp\u003e4.4 Interval estimation of the generalized odds ratio 66\u003c\/p\u003e \u003cp\u003e4.5 Sample size determination 67\u003c\/p\u003e \u003cp\u003e4.5.1 Sample size for testing non-equality 67\u003c\/p\u003e \u003cp\u003e4.5.2 Sample size for testing non-inferiority 68\u003c\/p\u003e \u003cp\u003e4.5.3 Sample size for testing equivalence 68\u003c\/p\u003e \u003cp\u003e4.6 Hypothesis testing and estimation for the period effect 70\u003c\/p\u003e \u003cp\u003e4.7 SAS codes for the proportional odds model with normal random effects 72\u003c\/p\u003e \u003cp\u003eExercises 74\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 AB\/BA design in frequency data 75\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Testing non-equality of treatments 78\u003c\/p\u003e \u003cp\u003e5.2 Testing non-inferiority of an experimental treatment to an active control treatment 81\u003c\/p\u003e \u003cp\u003e5.3 Testing equivalence between an experimental treatment and an active control treatment 83\u003c\/p\u003e \u003cp\u003e5.4 Interval estimation of the ratio of mean frequencies 84\u003c\/p\u003e \u003cp\u003e5.5 Sample size determination 86\u003c\/p\u003e \u003cp\u003e5.5.1 Sample size for testing non-equality 86\u003c\/p\u003e \u003cp\u003e5.5.2 Sample size for testing non-inferiority 87\u003c\/p\u003e \u003cp\u003e5.5.3 Sample size for testing equivalence 88\u003c\/p\u003e \u003cp\u003e5.6 Hypothesis testing and estimation for the period effect 88\u003c\/p\u003e \u003cp\u003e5.7 Estimation of the relative treatment effect in the presence of differential carry-over effects 90\u003c\/p\u003e \u003cp\u003eExercises 92\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Three-treatment three-period crossover design in continuous data 95\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Testing non-equality between treatments and placebo 102\u003c\/p\u003e \u003cp\u003e6.2 Testing non-inferiority of an experimental treatment to an active control treatment 103\u003c\/p\u003e \u003cp\u003e6.3 Testing equivalence between an experimental treatment and an active control treatment 104\u003c\/p\u003e \u003cp\u003e6.4 Interval estimation of the mean difference 104\u003c\/p\u003e \u003cp\u003e6.5 Hypothesis testing and estimation for period effects 105\u003c\/p\u003e \u003cp\u003e6.6 Procedures for testing treatment-by-period interactions 107\u003c\/p\u003e \u003cp\u003e6.7 SAS program codes and results for constant variance 109\u003c\/p\u003e \u003cp\u003eExercises 111\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Three-treatment three-period crossover design in dichotomous data 115\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Testing non-equality of treatments 121\u003c\/p\u003e \u003cp\u003e7.1.1 Asymptotic test procedures 121\u003c\/p\u003e \u003cp\u003e7.1.2 Exact test procedures 123\u003c\/p\u003e \u003cp\u003e7.1.3 Procedures for simultaneously testing non-equality of two experimental treatments versus a placebo 124\u003c\/p\u003e \u003cp\u003e7.2 Testing non-inferiority of an experimental treatment to an active control treatment 126\u003c\/p\u003e \u003cp\u003e7.3 Testing equivalence between an experimental treatment and an active control treatment 127\u003c\/p\u003e \u003cp\u003e7.4 Interval estimation of the odds ratio 129\u003c\/p\u003e \u003cp\u003e7.5 Hypothesis testing and estimation for period effects 131\u003c\/p\u003e \u003cp\u003e7.6 Procedures for testing treatment-by-period interactions 133\u003c\/p\u003e \u003cp\u003e7.7 SAS program codes and results for a logistic regression model with normal random effects 136\u003c\/p\u003e \u003cp\u003eExercises 138\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Three-treatment three-period crossover design in ordinal data 141\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Testing non-equality of treatments 150\u003c\/p\u003e \u003cp\u003e8.1.1 Asymptotic test procedures 150\u003c\/p\u003e \u003cp\u003e8.1.2 Exact test procedure 152\u003c\/p\u003e \u003cp\u003e8.2 Testing non-inferiority of an experimental treatment to an active control treatment 153\u003c\/p\u003e \u003cp\u003e8.3 Testing equivalence between an experimental treatment and an active control treatment 153\u003c\/p\u003e \u003cp\u003e8.4 Interval estimation of the GOR 154\u003c\/p\u003e \u003cp\u003e8.5 Hypothesis testing and estimation for period effects 156\u003c\/p\u003e \u003cp\u003e8.6 Procedures for testing treatment-by-period interactions 159\u003c\/p\u003e \u003cp\u003e8.7 SAS program codes and results for the proportional odds model with normal random effects 160\u003c\/p\u003e \u003cp\u003eExercises 162\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 Three-treatment three-period crossover design in frequency data 164\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Testing non-equality between treatments and placebo 170\u003c\/p\u003e \u003cp\u003e9.2 Testing non-inferiority of an experimental treatment to an active control treatment 173\u003c\/p\u003e \u003cp\u003e9.3 Testing equivalence between an experimental treatment and an active control treatment 174\u003c\/p\u003e \u003cp\u003e9.4 Interval estimation of the ratio of mean frequencies 175\u003c\/p\u003e \u003cp\u003e9.5 Hypothesis testing and estimation for period effects 178\u003c\/p\u003e \u003cp\u003e9.6 Procedures for testing treatment-by-period interactions 179\u003c\/p\u003e \u003cp\u003eExercises 181\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Three-treatment (incomplete block) crossover design in continuous and dichotomous data 183\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Continuous data 185\u003c\/p\u003e \u003cp\u003e10.1.1 Testing non-equality of treatments 188\u003c\/p\u003e \u003cp\u003e10.1.2 Testing non-equality between experimental treatments (or non-nullity of dose effects) 189\u003c\/p\u003e \u003cp\u003e10.1.3 Interval estimation of the mean difference 190\u003c\/p\u003e \u003cp\u003e10.1.4 SAS codes for fixed effects and mixed effects models 192\u003c\/p\u003e \u003cp\u003e10.2 Dichotomous data 194\u003c\/p\u003e \u003cp\u003e10.2.1 Testing non-equality of treatments 197\u003c\/p\u003e \u003cp\u003e10.2.2 Testing non-equality between experimental treatments (or non-nullity of dose effects) 199\u003c\/p\u003e \u003cp\u003e10.2.3 Testing non-inferiority of either experimental treatment to an active control treatment 199\u003c\/p\u003e \u003cp\u003e10.2.4 Interval estimation of the odds ratio 200\u003c\/p\u003e \u003cp\u003e10.2.5 SAS codes for the likelihood-based approach 202\u003c\/p\u003e \u003cp\u003eExercises 203\u003c\/p\u003e \u003cp\u003eReferences 208\u003c\/p\u003e \u003cp\u003eIndex 216\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49528847270231,"sku":"9781119114680","price":73.95,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781119114680.jpg?v=1731873257"},{"product_id":"clinical-trials-9780128042175","title":"Clinical Trials","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e1. The Origins of Drugs 2. Introduction to Clinical Trial Design 3. Run-in Period 4. Inclusion\/Exclusion Criteria, Stratification and Subgroups – Part I 5. Inclusion and Stratification Criteria – Part II 6. Randomization, Allocation, and Binding 7. Intent to Treat Analysis vs. Per Protocol Analysis 8. Biostatistics – Part I 9. Biostatistics – Part II 10. Introduction to Endpoints for Clinical Trials in Pharmacology 11. Endpoints in Clinical Trials on Solid Tumors – Objective Response 12. Oncology Endpoints: Overall Survival and Profession-Free Survival 13. Oncology Endpoints:  Time to Progression 14. Oncology Endpoint: Disease-Free Survival 15. Oncology Endpoint: Time to Distant Metastasis 16. Neoadjuvant Therapy vs. Adjuvant Therapy 17. Hematological Cancers 18. Biomarkers and Personalized Medicine 19. Endpoints in Immune Diseases 20. Endpoints in Clinical Trials on Infections 21. Health-Related Quality of Life 22. Health-Related Quality of Life Instruments for Immune Disorders 23. Health-Related Quality of Life Instruments and Infections 24. Drug Safety 25. Mechanisms of Action, Part I 26. Mechanisms of Action, Part II – Cancer 27. Mechanisms of Action, Part III – Immune Disorders  28. Mechanisms of Action, Part IV- Infections 29. Consent Forms 30. Package Inserts 31. Regulatory Approval 32. Patents","brand":"Elsevier Science","offers":[{"title":"Default Title","offer_id":51017542238551,"sku":"9780128042175","price":71.09,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780128042175.jpg?v=1750773886"},{"product_id":"laboratory-animal-anaesthesia-and-analgesia-9780128182680","title":"Laboratory Animal Anaesthesia and Analgesia","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e1. An introduction to Anaesthesia and Anaesthetic Equipment 2. Anaesthetic agents 3. Monitoring and Managing Anaesthesia 4. Specialised techniques 5. Analgesia and Post-operative care 6. Anaesthesia of Common Laboratory Species   Appendix 1. Physiological data 2. Estimation of use of inhalational agents and carrier gases 3. Calculations of dilutions of anaesthetic mixtures for small rodents 4. Manufacturers of equipment and other items illustrated or cited in the text","brand":"Book Curl","offers":[{"title":"Default Title","offer_id":51017549283671,"sku":"9780128182680","price":81.9,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780128182680.jpg?v=1750773909"},{"product_id":"essentials-of-translational-pediatric-drug-development-9780323884594","title":"Essentials of Translational Pediatric Drug","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e","brand":"Elsevier Science","offers":[{"title":"Default Title","offer_id":51017776136535,"sku":"9780323884594","price":121.5,"currency_code":"GBP","in_stock":false}]},{"product_id":"sample-size-calculations-in-clinical-research-9780367657765","title":"Sample Size Calculations in Clinical Research","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePraise for the Second Edition:\u003c\/p\u003e\u003cp\u003eâ this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study. -\u003cb\u003e\u003ci\u003eBiometrics\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003ci\u003eThis impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered â\u003c\/i\u003e â \u003cb\u003e\u003ci\u003eJournal of the Royal Statistical Society\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003cb\u003eSample Size Calculations in Clinical Research, Third Edition\u003c\/b\u003e presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003c\/p\u003e\u003cp\u003ePraise for the Second Edition:\u003c\/p\u003e\u003cp\u003e\"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study.\" -\u003cb\u003e\u003ci\u003eBiometrics\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003e\"\u003ci\u003eThis impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered …\u003c\/i\u003e\" – \u003cb\u003e\u003ci\u003eJournal of the Royal Statistical Society\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003e\u003cem\u003e\"\u003c\/em\u003e\u003c\/strong\u003eThe book is nicely set out with an introduction to the basic idea of each topic, followed by various formulae that lead to power calculations . . . In all, I consider this book to be well written, and it touches on quite a number of more recent topics in sample size determination. Consequently, it will be a useful addition to clinical statisticians as a point of reference to solve more complex issues in power calculations during the design of a clinical trial.\" – \u003cem\u003e\u003cstrong\u003eSteve Su, \u003c\/strong\u003e\u003cb\u003eInternational Society for Clinical Biostatistics\u003c\/b\u003e\u003c\/em\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eSample Size Calculations in Clinical Research, Third Edition\u003c\/strong\u003e presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation.\u003c\/p\u003e\u003cp\u003eFeatures:\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003e \u003c\/p\u003e \u003c\/li\u003e\n\u003cli\u003eCompares the relative merits and disadvantages of statistical methods for sample size calculations\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e \u003c\/p\u003e \u003c\/li\u003e\n\u003cli\u003eExplains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e \u003c\/p\u003e \u003c\/li\u003e\n\u003cli\u003ePresents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e \u003c\/p\u003e \u003c\/li\u003e\n\u003cli\u003eProvides sample size calculations for dose response studies, microarray studies, and Bayesian approaches\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eThis new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.\u003c\/p\u003e\u003cbr\u003e\u003cp\u003ePraise for the Second Edition:\u003c\/p\u003e\u003cp\u003e\"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study.\" -\u003cb\u003e\u003ci\u003eBiometrics\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\u003cp\u003e\"\u003ci\u003eThis impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered …\u003c\/i\u003e\" – \u003cstrong\u003e\u003cem\u003eJournal of the Royal Statistical Society\u003c\/em\u003e\u003c\/strong\u003e\u003cstrong\u003e\u003cem\u003e\"\u003c\/em\u003e\u003c\/strong\u003eThe book is nicely set out with an introduction to the basic idea of each topic, followed by various formulae that lead to power calculations . . . In all, I consider this book to be well written, and it touches on quite a number of more recent topics in sample size determination. Consequently, it will be a useful addition to clinical statisticians as a point of reference to solve more complex issues in power calculations during the design of a clinical trial.\" – \u003cem\u003e\u003cstrong\u003eSteve Su, \u003c\/strong\u003e\u003cb\u003eInternational Society for Clinical Biostatistics\u003c\/b\u003e\u003c\/em\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eSample Size Calculations in Clinical Research, Third Edition\u003c\/strong\u003e presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation.\u003c\/p\u003e\u003cp\u003eFeatures:\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003e \u003c\/p\u003e \u003c\/li\u003e\n\u003cli\u003eCompares the relative merits and disadvantages of statistical methods for sample size calculations\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e \u003c\/p\u003e \u003c\/li\u003e\n\u003cli\u003eExplains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e \u003c\/p\u003e \u003c\/li\u003e\n\u003cli\u003ePresents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health\u003c\/li\u003e\n\u003cli\u003e\n\u003cp\u003e \u003c\/p\u003e \u003c\/li\u003e\n\u003cli\u003eProvides sample size calculations for dose response studies, microarray studies, and Bayesian approaches\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eThis new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eIntroduction. Considerations Prior to Sample Size Calculation. Comparing Means. Large Sample Tests for Proportions. Exact Tests for Proportions. Tests for Goodness-of-Fit and Contingency Tables. Comparing Time-to-Event Data. Group Sequential Methods. Comparing Variabilities. Bioequivalence Testing. Dose Resonse Studies. Microarray Studies. Bayesian Sample Size Calculation. Nonparametrics. Cluster Randomized Design. Sample Size Calculation for Two-Stage Adaptive Design. Sample Size for Clinical Trials with Extremely Low Incidence Rates. Clinical Trial Simulation for Sample Size Estimation. Sample Size Calculation in Other Areas. \u003c\/p\u003e","brand":"CRC Press","offers":[{"title":"Default Title","offer_id":51018007249239,"sku":"9780367657765","price":999.99,"currency_code":"GBP","in_stock":false}]},{"product_id":"realworld-evidence-in-a-patientcentric-digital-era-9780367861810","title":"RealWorld Evidence in a PatientCentric Digital","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cem\u003eReal-world evidence\u003c\/em\u003e is defined as evidence generated from real-world data outside randomized controlled trials. As scientific discoveries and methodologies continue to advance, real-world data and their companion technologies offer powerful new tools for evidence generation. \u003cb\u003eReal-World Evidence in a Patient-Centric Digital Era\u003c\/b\u003e provides perspectives, examples, and insights on the innovative application of real-world evidence to meet patient needs and improve healthcare, with a focus on the pharmaceutical industry.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis book presents an overview of key analytical issues and best practices. Special attention is paid to the development, methodologies, and other salient features of the statistical and data science techniques that are customarily used to generate real-world evidence. It provides a review of key topics and emerging trends in cutting-edge data science and health innovation.\u003c\/p\u003e\u003cb\u003e\u003c\/b\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eFeatures:\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eProvides an overview \u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePreface: Real World Evidence and Digital Innovation to Combat Noncommunicable Diseases. 1. Real World Evidence Generation. 2. Applications of RWE for Regulatory Uses. 3. Ethics \u0026amp; Bioethics. 4. Real- World Data, Big Data and Artificial Intelligence: Recent Development and Emerging Trends in the European Union. 5. Patient centricity and Precision Medicine. 6. Health Information Technology. 7. Digital Health Technologies and Innovations. 8. Economic Analysis and Outcome Assessment. 9. Partnerships and Collaborations. 10. Global Perspective: China Big Data Collaboration to Improve Patient Care. 11. The Future of Patient-Centric Data-Driven Healthcare\u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":51018081632599,"sku":"9780367861810","price":99.75,"currency_code":"GBP","in_stock":true}]},{"product_id":"synopsis-of-key-gynecologic-oncology-trials-9781032135328","title":"Synopsis of Key Gynecologic Oncology Trials","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eThis revised and updated new edition of a best-selling text remains a fast and convenient overview of the clinical trials in gynecologic cancer treatment, outlining the evidence base of treatment decisions in uterine, ovarian, cervical, and vulvar cancers, and gestational trophoblastic neoplasia. Residents and fellows will find this book an indispensable reference, while practitioners will welcome it as a clarification of the evidence base for treatment options. \u003c\/p\u003e\u003cp\u003e*Gives a convenient summary of trials in gynecologic oncology \u003cbr\u003e*Supplies an invaluable revision primer for those undertaking certification \u003cbr\u003e*Provides a uniquely up-to-date resource\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cstrong\u003ePreface to the second edition\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003e1. Uterine Malignancies.\u003c\/strong\u003e 1.1. Endometrial Carcinoma. 1.1.1. Studies addressing surgical treatment. 1.1.1.1. Lymph node assessment 1.1.2. Studies addressing adjuvant therapy. 1.1.2.1. Radiation. 1.1.2.2. Chemoradiation. 1.1.2.3. Chemotherapy. 1.1.3. Studies addressing treatment of recurrent endometrial carcinoma. 1.1.3.1. Hormonal therapy. 1.1.3.2. Chemotherapy. 1.1.3.3. Targeted therapy. 1.1.3.4. Immunotherapy. 1.2. Uterine Carcinosarcoma. 1.2.1. Studies addressing prognosticators. 1.2.2. Studies addressing adjuvant treatment. 1.2.3. Studies addressing treatment of advanced\/ recurrent uterine carcinosarcoma. 1.3. Uterine Leiomyosarcoma. 1.3.1. Studies addressing adjuvant treatment of early stage uterine leiomyosarcoma. 1.3.2. Studies addressing treatment of advanced uterine leiomyosarcoma. 1.4. References.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003e2. Ovarian Malignancies.\u003c\/strong\u003e 2.1. Epithelial ovarian cancer (EOC). 2.1.1. Studies addressing upfront surgery. 2.1.2. Studies addressing adjuvant therapy. 2.1.3. Studies addressing intraperitoneal chemotherapy. 2.1.4. Studies addressing first line maintenance treatment. 2.1.5. Studies addressing neoadjuvant therapy. 2.1.6. Studies addressing prediction of debulking. 2.1.7. Studies addressing time point of treatment of recurrence. 2.1.8. Studies addressing treatment of recurrent ovarian cancer, platinum-sensitive. 2.1.8.1. Chemotherapy and targeted therapy. 2.1.8.2. Secondary debulking surgery. 2.1.9. Studies addressing treatment of recurrent ovarian cancer, platinum-resistant. 2.1.9.1. Chemotherapy and targeted therapy. 2.1.9.2. Immunotherapy. 2.2. Low grade serous ovarian cancer. 2.3. Mucinous epithelial ovarian cancer (mEOC). 2.4. Ovarian Germ Cell Tumors (GCT). 2.5. Ovarian Sex Cord-Stromal Tumors (SCT). 2.6. References.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003e3. Cervical Cancer.\u003c\/strong\u003e 3.1. Studies addressing surgical treatment. 3.2. Studies addressing adjuvant therapy. 3.3. Studies addressing primary chemoradiation therapy. 3.4. Studies addressing treatment of recurrent or metastatic cervical cancer. 3.4.1. Chemotherapy and targeted therapy. 3.4.2. Immunotherapy. 3.5. References.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003e4. Vulvar Cancer.\u003c\/strong\u003e 4.1. Studies addressing surgical treatment. 4.1.1. Groin lymph nodes. 4.2. Studies addressing advanced vulvar cancer. 4.2.1. Chemoradiation. 4.2.2. Immunotherapy. 4.3. References.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003e5. Gestational Trophoblastic Neoplasia (GTN).\u003c\/strong\u003e 5.1. Studies addressing surgical treatment. 5.2. Studies addressing chemotherapy in low-risk GTN. 5.3. Studies addressing (chemo)therapy in high-risk GTN. 5.4. References.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003e6. Glossary. Index.\u003c\/strong\u003e\u003c\/p\u003e","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":51018859643223,"sku":"9781032135328","price":44.99,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781032135328.jpg?v=1750778424"},{"product_id":"realworld-evidence-in-a-patientcentric-digital-era-9781032303628","title":"RealWorld Evidence in a PatientCentric Digital","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cem\u003eReal-world evidence\u003c\/em\u003e is defined as evidence generated from real-world data outside randomized controlled trials. As scientific discoveries and methodologies continue to advance, real-world data and their companion technologies offer powerful new tools for evidence generation. \u003cb\u003eReal-World Evidence in a Patient-Centric Digital Era\u003c\/b\u003e provides perspectives, examples, and insights on the innovative application of real-world evidence to meet patient needs and improve healthcare, with a focus on the pharmaceutical industry.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eThis book presents an overview of key analytical issues and best practices. Special attention is paid to the development, methodologies, and other salient features of the statistical and data science techniques that are customarily used to generate real-world evidence. It provides a review of key topics and emerging trends in cutting-edge data science and health innovation.\u003c\/p\u003e\u003cb\u003e\u003c\/b\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eFeatures:\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eProvides an overview\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":51018959749463,"sku":"9781032303628","price":42.74,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781032303628.jpg?v=1750778824"},{"product_id":"quality-control-and-regulatory-aspects-for-biologicals-9781032697406","title":"Quality Control and Regulatory Aspects for","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eThis book serves as a comprehensive guide on quality control and regulatory aspects for biological products. It covers a wide range of topics, including regulatory requirements, quality control strategies, analytical methods, and risk management. It delves into the advantages and limitations of in vivo tests and discusses alternative methods that can be employed. The book explores the use of animal-based testing methods in quality control and examines viable alternatives.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eKey Features:\u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eReviews various scientific and regulatory aspects involved in the quality control of biologicals\u003c\/li\u003e\n\u003cli\u003eProvides an overview of the roles of various national and international regulatory bodies and accreditation agencies\u003c\/li\u003e\n\u003cli\u003ePresents advanced analytical methods, innovative technologies, and the integration of molecular diagnostics in quality control processes\u003c\/li\u003e\n\u003cli\u003eExplores the use of animal-based testing methods in quality control, as well as their alternative\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":51019164844375,"sku":"9781032697406","price":87.39,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781032697406.jpg?v=1750779515"},{"product_id":"statistical-thinking-in-clinical-trials-9781138058569","title":"Statistical Thinking in Clinical Trials","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cstrong\u003eStatistical Thinking in Clinical Trials\u003c\/strong\u003e combines a relatively small number of key statistical principles and several instructive clinical trials to gently guide the reader through the statistical thinking needed in clinical trials. Randomization is the cornerstone of clinical trials and randomization-based inference is the cornerstone of this book. Read this book to learn the elegance and simplicity of re-randomization tests as the basis for statistical inference (the analyze as you randomize principle) and see how re-randomization tests can save a trial that required an unplanned, mid-course design change. \u003c\/p\u003e\u003cp\u003eOther principles enable the reader to quickly and confidently check calculations without relying on computer programs. The `EZ' principle says that a single sample size formula can be applied to a multitude of statistical tests. The `O minus E except after V' principle provides a simple estimator of the log odds ratio that is ideally suited for stratified\u003c\/p\u003e","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":51019452842327,"sku":"9781138058569","price":50.34,"currency_code":"GBP","in_stock":true}]},{"product_id":"sample-sizes-for-clinical-trials-9781138587892","title":"Sample Sizes for Clinical Trials","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cstrong\u003eSample Sizes for Clinical Trials, Second Edition\u003c\/strong\u003e is a practical book that assists researchers in their estimation of the sample size for clinical trials. Throughout the book there are detailed worked examples to illustrate both how to do the calculations and how to present them to colleagues or in protocols. The book also highlights some of the pitfalls in calculations as well as the key steps that lead to the final sample size calculation.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cb\u003e\u003c\/b\u003e\u003cp\u003eFeatures:\u003c\/p\u003e\u003cul\u003e\n\u003cp\u003e\u003c\/p\u003e\n\u003cli\u003eComprehensive coverage of sample size calculations, including Normal, binary, ordinal, and survival outcome data\u003c\/li\u003e\n\u003cli\u003eCovers superiority, equivalence, non-inferiority, bioequivalence and precision objectives for both parallel group and crossover designs\u003c\/li\u003e\n\u003cli\u003eHighlights how trial objectives impact the study design with respect to both the derivation of sample formulae and the size of the study\u003c\/li\u003e\n\u003cli\u003eMotivated with examples of real-life clinical trials showing how the calculations\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e1. Introduction. 2.Seven Key Steps to Cook up a Sample Size. 3. Sample Sizes for Parallel Group Superiority Trials with Normal Data. 4. Sample Size Calculations for Superiority Cross-Over Trials with Normal Data. 5. Sample Size for Cluster Randomized Trials. 6. Allowing for Multiplicity in Sample Sizes Calculations for Clinical Trials. 7. Samples Size Calculations for Non-Inferiority Clinical Trials with Normal Data. 8. Sample Size Calculations for Equivalence Clinical Trials with Normal Data. 9. Sample Size Calculations for Bioequivalence Trials. 1. Sample Size Calculations for Precision Clinical Trials with Normal Data. Sample Size for Pilot Studies. 12. Sample Size Calculations for Parallel Group Superiority Clinical Trials with Binary Data. 13. Sample Size Calculations for Superiority Cross-Over Clinical Trials with Binary Data. 14. Sample Size Calculations for Non-Inferiority Trials with Binary Data. 15. Sample Size Calculations for Equivalence Trials with Binary Data. 16. Sample Size Calculations for Precision Trials with Binary Data. 17. Sample Size Calculations for Single Arm Clinical Trials and Studies with Finite Population Size. 18. Sample Sizes for Clinical Trials with an Adaptive Design. 19. Sample Size Calculations for Clinical Trials with Ordinal Data. 20. Estimating the Number of Events for Clinical Trials with Survival Data for a Negative Outcome. 21. Sample Size Calculations for Clinical Trials with Survival Data and a Positive Outcome. 22. Sample Size Calculations for Clinical Trials with Survival Data Allowing for Recruitment and Withdrawal. 23. Appendix. 24. References. \u003c\/p\u003e\n\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":51019504451927,"sku":"9781138587892","price":87.39,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781138587892.jpg?v=1750780466"},{"product_id":"power-and-sample-size-in-r-9781138591622","title":"Power and Sample Size in R","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003ci\u003ePower and Sample Size in R\u003c\/i\u003e guides the reader through power and sample size calculations for a wide variety of study outcomes and designs and illustrates their implementation in R software. It is designed to be used as a learning tool for students as well as a resource for experienced statisticians and investigators.\u003c\/p\u003e\u003cp\u003eThe book begins by explaining the process of power calculation step by step at an introductory level and then builds to increasingly complex and varied topics. For each type of study design, the information needed to perform a calculation and the factors that affect power are explained. Concepts are explained with statistical rigor but made accessible through intuition and examples. Practical advice for performing sample size and power calculations for real studies is given throughout.\u003c\/p\u003e\u003cp\u003eThe book demonstrates calculations in R. It is integrated with the companion R package powertools and also draws on and summarizes the capabilities of other R packages.\u003c\/p\u003e","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":51019504812375,"sku":"9781138591622","price":71.24,"currency_code":"GBP","in_stock":true}]},{"product_id":"introduction-to-statistical-methods-for-clinical-trials-9781584880271","title":"Introduction to Statistical Methods for Clinical","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eClinical trials have become essential research tools for evaluating the benefits and risks of new interventions for the treatment and prevention of diseases, from cardiovascular disease to cancer to AIDS. Based on the authors’ collective experiences in this field, \u003cb\u003eIntroduction to Statistical Methods for Clinical Trials\u003c\/b\u003e presents various statistical topics relevant to the design, monitoring, and analysis of a clinical trial.\u003c\/p\u003e\u003cp\u003eAfter reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals. \u003c\/p\u003e\u003cp\u003eDeveloped from a course taught at the University of Wisconsin for the past 25 years, this textbook provides a solid understanding of the statistical approaches used in the design, conduct, and analysis of clinical trials.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e… There is much good material in this book. The individual chapters are well written and cover the technical aspects as well. A major strength is the ordering of topics to follow the thought process used in the development and implementation of a protocol from defining the question to reporting results. There are careful discussions on fundamental principles and the pivotal role played by statistics is well brought out. … there is much that practicing pharmaceutical statisticians will find useful in this book. They will find the coverage of fundamental principles useful and the technical content of the book a good reference source. …\u003cbr\u003e—\u003cem\u003ePharmaceutical Statistics\u003c\/em\u003e, 2010\u003c\/p\u003e\u003cp\u003e… fits the need for a contemporary text and handbook that is oriented toward the clinical trial statistician. I highly recommend it and look forward to using it as both a primary and supplemental text in our curriculum, as well as a research resource.\u003cbr\u003e—James J. Dignam, University of Chicago, \u003cem\u003eJASA\u003c\/em\u003e, March 2009\u003c\/p\u003e\u003cp\u003eThe (technical) statistical content is the main focus of the book and this is what helps it to stand apart from most others on clinical trials (even the more obviously statistically orientated ones). It takes the reader to quite a technical background that would serve him or her well if moving on to research problems in the various areas covered, yet does not lose sight of practical issues. … For those of us with the interest (and need) to grapple with these more statistical issues, I wholeheartedly recommend it.\u003cbr\u003e—\u003cem\u003eBiometrics\u003c\/em\u003e, December 2008\u003c\/p\u003e\u003cp\u003e…The book is very well written and clear. … the authors generally strike the right balance for the intended audience. The inclusion of many historically important as well as contemporary examples to illustrate various points throughout the text is a major strength, as is the inclusion of several modern topics not seen in other texts. As a basis for a course in clinical trials for graduate students in biostatistics, this book is outstanding. In addition, statisticians in the pharmaceutical industry, government, or academia … will find this text extremely informative and useful.” \u003cbr\u003e—Michael P. McDermott, University of Rochester Medical Center, \u003cem\u003eJournal of Biopharmaceutical Statistics\u003c\/em\u003e, 2008\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003ePreface. Introduction to Clinical Trials. Defining the Question. Study Design. Sample Size. Randomization. Data Collection and Quality Control. Survival Analysis. Longitudinal Data. Quality of Life. Data Monitoring and Interim Analysis. Selected Issues in the Analysis. Closeout and Reporting. Special Topics. Appendix. References. Index.","brand":"Taylor \u0026 Francis Inc","offers":[{"title":"Default Title","offer_id":51020086116695,"sku":"9781584880271","price":80.74,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781584880271.jpg?v=1750782352"},{"product_id":"clinical-trials-in-neurology-9780521762595","title":"Clinical Trials in Neurology","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eClinical Trials in Neurology provides the tools to enhance the development of new treatments for neurologic diseases through introducing the reader to key concepts underpinning trials in the neurosciences. This comprehensive guide is essential reading for neurologists, psychiatrists, neurosurgeons, neuroscientists, statisticians and clinical researchers in the pharmaceutical industry.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003ePreface; Part I. The Role of Clinical Trials in Therapy Development: 1. The impact of clinical trials in neurology E. Ray Dorsey and S. Claiborne Johnston; 2. The sequence of clinical development Michael Poole; 3. Unique challenges in the development of therapies for neurological disorders Gilmore N. O'Neill; Part II. Concepts in Biostatistics and Clinical Measurement: 4. Fundamentals of biostatistics Judith Bebchuk and Janet Wittes; 5. Bias and random error Susan S. Ellenberg and Jacqueline A. French; 6. Approaches to data analysis William R. Clarke; 7. Selecting outcome measures Robert G. Holloway and Andrew D. Siderowf; Part III. Special Study Designs and Methods for Data Monitoring: 8. Selection and futility designs Bruce Levin; 9. Adaptive designs across stages of therapeutic development Christopher S. Coffey; 10. Crossover designs Mary E. Putt; 11. Two period designs for evaluation of disease-modifying treatments Michael P. McDermott; 12. Enrichment designs Kathryn M. Kellogg and John Markman; 13. Non-inferiority trials Rick Chappell; 14. Monitoring of clinical trials: interim monitoring, data monitoring committees, and group sequential methods applied to neurology Rickey E. Carter and Robert F. Woolson; 15. Clinical approaches to post-marketing drug safety assessment Gerald J. Dal Pan; Part IV. Ethical Issues: 16. Ethics in clinical trials involving the central nervous system: risk, benefit, justice, and integrity Jonathan Kimmelman; 17. The informed consent process: compliance and beyond Scott Y. H. Kim; Part V. Regulatory Perspectives: 18. Evidentiary standards for neurologic drugs and biologics approval Russell Katz; 19. Premarket reviews of neurological devices Eric A. Mann and Peter G. Como; Part VI. Clinical Trials in Common Neurological Disorders: 20. Parkinson's disease Karl D. Kieburtz and Jordan Elm; 21. Alzheimer's disease Joshua Grill and Jeffrey Cummings; 22. Acute ischemic stroke Karen C. Johnston, Devin L. Brown and Yuko Y. Palesch; 23. Multiple sclerosis Richard A. Rudick, Elizabeth Fisher and Gary R. Cutter; 24. Amytrophic lateral sclerosis (ALS) Nazem Atassi, David Schoenfeld and Merit Cudkowicz; 25. Epilepsy John R. Pollard, Susan S. Ellenberg and Jacqueline A. French; 26. Insomnia Michael E. Yurcheshen, Changyong Feng and J. Todd Arnedt; Part VII. Clinical Trial Planning and Implementation: 27. Clinical trial planning: an academic and industry perspective Cornelia L. Kamp and Jean-Michel Germain; 28. Clinical trial implementation, analysis and reporting: an academic and industry perspective Cornelia L. Kamp and Jean-Michel Germain; 29. Academic-industry collaborations and compliance issues Troy Morgan; Index.","brand":"Cambridge University Press","offers":[{"title":"Default Title","offer_id":51767733551447,"sku":"9780521762595","price":97.85,"currency_code":"GBP","in_stock":true}]},{"product_id":"dose-finding-designs-for-early-phase-cancer-clinical-trials-a-brief-guidebook-to-theory-and-practice-9784431555841","title":"Dose-Finding Designs for Early-Phase Cancer Clinical Trials: A Brief Guidebook to Theory and Practice","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eThis book provides a comprehensive introduction to statistical methods for designing early phase dose-finding clinical trials. It will serve as a textbook or handbook for graduate students and practitioners in biostatistics and clinical investigators who are involved in designing, conducting, monitoring, and analyzing dose-finding trials. The book will also provide an overview of advanced topics and discussions in this field for the benefit of researchers in biostatistics and statistical science. Beginning with backgrounds and fundamental notions on dose finding in early phase clinical trials, the book then provides traditional and recent dose-finding designs of phase I trials for, e.g., cytotoxic agents in oncology, to evaluate toxicity outcome. Included are rule-based and model-based designs, such as 3 + 3 designs, accelerated titration designs, toxicity probability interval designs, continual reassessment method and related designs, and escalation overdose control designs. This book also covers more complex and updated dose-finding designs of phase I-II and I\/II trials for cytotoxic agents, and cytostatic agents, focusing on both toxicity and efficacy outcomes, such as designs with covariates and drug combinations, maximum tolerated dose-schedule finding designs, and so on.\u003cbr\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e“The book under review is intended to serve as a brief handbook for graduate students and biostatistics, as well as for oncologists who are involved in the analysis of methods for developing optimal doses for treating cancer in the early stages.” (Fatima T. Adylova, zbMATH 1427.92001, 2020)\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e1. Introduction.- 2. Dose Finding in Early Phase Clinical Trials.- 3. Rule.- Based Designs.- 4. Continual Reassessment Method Designs.- 5. Escalation with Overdose Control Designs.- 6. Decision.- Theoretic Designs.- 7. Complex Designs.\u003c\/p\u003e","brand":"Springer Verlag, Japan","offers":[{"title":"Default Title","offer_id":51772112470359,"sku":"9784431555841","price":49.99,"currency_code":"GBP","in_stock":true}]},{"product_id":"causal-inference-in-pharmaceutical-statistics-9781032560144","title":"Causal Inference in Pharmaceutical Statistics","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003ci\u003eCausal Inference in Pharmaceutical Statistics\u003c\/i\u003e introduces the basic concepts and fundamental methods of causal inference relevant to pharmaceutical statistics. This book covers causal thinking for different types of commonly used study designs in the pharmaceutical industry, including but not limited to randomized controlled clinical trials, longitudinal studies, singlearm clinical trials with external controls, and real-world evidence studies. The book starts with the central questions in drug development and licensing, takes the reader through the basic concepts and methods via different study types and through different stages, and concludes with a roadmap to conduct causal inference in clinical studies. The book is intended for clinical statisticians and epidemiologists working in the pharmaceutical industry. It will also be useful to graduate students in statistics, biostatistics, and data science looking to pursue a career in the pharmaceutical industry.\u003c\/p\u003e\u003cp\u003eKey Featur\u003c\/p\u003e","brand":"Taylor \u0026 Francis Ltd","offers":[{"title":"Default Title","offer_id":51926146318679,"sku":"9781032560144","price":87.39,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781032560144.jpg?v=1760622357"},{"product_id":"a-practical-guide-to-human-research-and-clinical-trials-9781466591172","title":"A Practical Guide to Human Research and Clinical Trials","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eRegulatory bodies such as the European Medicine Agency have done tremendous work in collaboration with experts from the field to develop Good Clinical Practices that apply not only in Europe but also in emerging countries. Designed to be a teaching aid and reference guide, \u003cb\u003eA Practical Guide to Human Research and Clinical\u003c\/b\u003e focuses on ethics, regulations, and guidelines.\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eConducting a successful clinical trial requires not only a strong basic knowledge, but also hands-on practical training. The book explains the intricate details of the subject to readers by citing concrete cases, exercises, and templates along with the theoretical aspects. Prof. M.U.R Naidu and his co-authors address all aspects of clinical trials from clinical research, drug development, and quality to methodology, biostatistics, and pharmacovigilance.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cstrong\u003eClinical Research – A Clinical Investigator’s Perspective\u003cbr\u003e\u003c\/strong\u003eIntroduction \u003cbr\u003eScientific and Practical Aspects \u003cbr\u003eFinancial Considerations\u003cbr\u003e\u003cbr\u003e\u003cb\u003eMedical Device Development, Process and Regulation\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eCategories of Medical Devices \u003cbr\u003eEvaluation of Medical Devices \u003cbr\u003eRegulatory Process \u003cbr\u003e\u003cbr\u003e\u003cb\u003ePre-Clinical Drug Development\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eOverview of Drug Discovery and Role of basic Sciences \u003cbr\u003eNew Approaches in Drug Discovery \u003cbr\u003ePharmacological Screening \u003cbr\u003e\u003cbr\u003e\u003cb\u003ePhases of Clinical Trials\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003ePhase I \u003cbr\u003ePhase II Studies \u003cbr\u003ePhase III Trials \u003cbr\u003ePhase IV Trials \u003cbr\u003e\u003cbr\u003ePhase 0 - Microdosing Studies\u003cbr\u003eIntroduction \u003cbr\u003eMicro-dosing and Exploratory-IND Studies\u003cbr\u003eCharacteristics of an Ideal Candidate Drug for Phase 0-Micro-dosing Studies \u003cbr\u003eGoals of Microdosing Studies\u003cbr\u003eTechnical Advances \u003cbr\u003eRegulatory Issues\u003cbr\u003ePatient’s Perspective\u003cbr\u003eInformed Consent Issues \u003cbr\u003eSingle-dose Toxicity Study in Support of Micro-dosing Studies\u003cbr\u003eAdvantages of Micro-dosing\u003cbr\u003eLimitations of Micro-dosing \u003cbr\u003eConclusion \u003cbr\u003e\u003cbr\u003e\u003cb\u003eClinical Research Planning\u003cbr\u003e\u003c\/b\u003eIntroduction to Clinical Trials \u003cbr\u003eTypes of Clinical Trials\u003cbr\u003eThe Planning Steps\u003cbr\u003e\u003cbr\u003e\u003cb\u003eClinical Research Design\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eElements of Trial Design\u003cbr\u003eTypes of Clinical Trial Design\u003cbr\u003e\u003ci\u003e\u003cbr\u003e\u003c\/i\u003e\u003cb\u003eClinical Research Protocol\u003cbr\u003e\u003c\/b\u003eTitle Page \u003cbr\u003eSignature Page\u003cbr\u003eContents Page \u003cbr\u003eList of Abbreviations and Definitions \u003cbr\u003eSummary \u003cbr\u003eBackground\u003cbr\u003eTrial Objectives and Purpose \u003cbr\u003eStudy Design\u003cbr\u003eSubject Selection \u003cbr\u003eSubject Recruitment \u003cbr\u003eTrial Interventions \u003cbr\u003eRandomisations \u003cbr\u003eBlinding \u003cbr\u003eData \u003cbr\u003eStatistical Considerations \u003cbr\u003eCompliance and Withdrawal \u003cbr\u003eInterim Analysis and Data Monitoring\u003cbr\u003eEthical Considerations \u003cbr\u003eFinancing and Insurance \u003cbr\u003eReporting and Publication \u003cbr\u003e\u003cbr\u003e\u003cb\u003eDesigning Case Report Forms\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eUses of CRF\u003cbr\u003eWell-Designed CRF \u003cbr\u003eCRF Design Layout \u003cbr\u003eCRF Field Designs \u003cbr\u003eCRF Verification Before Use \u003cbr\u003eElements of Trial Design \u003cbr\u003eElectronic Data Entry Forms \u003cbr\u003eConclusion \u003cbr\u003ePoints to Remember \u003cbr\u003e\u003cbr\u003eProcess of Randomization in Clinical Trials\u003cbr\u003eIntroduction \u003cbr\u003eAdvantages of Randomization \u003cbr\u003eTypes of Randomization \u003cbr\u003eTechniques of Randomisation \u003cbr\u003eImplementation of Randomization Procedure \u003cbr\u003e\u003cbr\u003e\u003cb\u003eInvestigational Medicinal Products\u003cbr\u003e\u003c\/b\u003eDefinition \u003cbr\u003eManufacturing, Packaging, Labeling, and Coding IMPs\u003cbr\u003eSupply and Handling IMPs \u003cbr\u003eReceipt of IMP, Inventory, Storage and Accountability \u003cbr\u003eRandomization Code \u003cbr\u003ePrinciples Applicable to Comparator Product \u003cbr\u003eBlinding Operations \u003cbr\u003eRecall, Return, Shipment and Destruction of IMP \u003cbr\u003e\u003cbr\u003e\u003cb\u003eMulti-center Clinical Trials\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eAdvantages and Disadvantages\u003cbr\u003eA Common Protocol \u003cbr\u003eA Coordinating Centre \u003cbr\u003eComparability of Participating institutions \u003cbr\u003eCommittees in a Multi-center Trial \u003cbr\u003eStatistical Issues \u003cbr\u003eAnalysis of Results \u003cbr\u003eMultinational Clinical Trials \u003cbr\u003e\u003ci\u003e\u003cbr\u003e\u003c\/i\u003e\u003cb\u003eGood Clinical Research Practice\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eDefinition of GCP\u003cbr\u003eOverview of the Clinical Research Process \u003cbr\u003ePrinciples of GCP\u003cbr\u003e\u003cbr\u003e\u003cb\u003eRole and Responsibilities of Sponsor\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eContract Research Organization (CRO) \u003cbr\u003eThe Sponsor and the investigational Products \u003cbr\u003eSponsor and Record Access \u003cbr\u003eSafety Information \u003cbr\u003e\u003cbr\u003e\u003cb\u003eRole and Responsibilities of Principal Investigator\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eCompetencies and Responsibilities of the Principal Investigator \u003cbr\u003eQualifications and Availability \u003cbr\u003eAdequate Resources \u003cbr\u003eInformed Consent \u003cbr\u003eInvestigational Products \u003cbr\u003eCompliance with Protocol \u003cbr\u003eMonitoring and Auditing \u003cbr\u003eSource Data and Other Documentation \u003cbr\u003eSafety Issues and Reporting of Serious Adverse Events \u003cbr\u003ePremature Termination - Breaking the Treatment Code \u003cbr\u003eProgress Reports, Trial Outcome and Final Study Reports \u003cbr\u003e\u003cbr\u003e\u003cb\u003eEthical Consideration in Clinical Research – Special Reference to Developing Countries\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eIndividuals Involved With Ethical Issues \u003cbr\u003eEthical Issues Related to Protocol Development and Study Design\u003cbr\u003eIssues on Informed Consent \u003cbr\u003eEthical Issues During Conduct of a Clinical Research \u003cbr\u003eAccess to Post Trial Benefits \u003cbr\u003eNeed for Developed Countries to Assist Developing\u003cbr\u003eCountries in Capacity Building \u003cbr\u003e\u003cbr\u003e\u003cb\u003eInformed Consent in Clinical Research\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eHistorical Background \u003cbr\u003eElements of Informed Consent \u003cbr\u003eLanguage Used in Consent Forms \u003cbr\u003eInformed Consent Waiver \u003cbr\u003eRevising an Informed Consent\u003cbr\u003eReconsenting Process \u003cbr\u003eConsent Obtained from Special Groups of Patients \u003cbr\u003e\u003cbr\u003e\u003cb\u003eMonitoring in Clinical Trials\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eTypes of Monitoring in Clinical Trials \u003cbr\u003eKey Participant in Monitoring of Clinical Trial \u003cbr\u003e\u003cbr\u003e\u003cb\u003eQuality Assurance in Clinical Research\u003cbr\u003e\u003c\/b\u003eMonitoring-Details Presented in Chapter on Monitoring \u003cbr\u003eAudit \u003cbr\u003eInspections \u003cbr\u003eData Management Metrics \u003cbr\u003e\u003cbr\u003e\u003cb\u003ePharmacovigilance and Drug Safety\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eTerms Commonly Used in Drug Safety \u003cbr\u003eThe Specific Aims of Pharmacovigilance \u003cbr\u003eDefinitions \u003cbr\u003eADR Classification and Evolution \u003cbr\u003eCausality Assessment Scales \u003cbr\u003eImportant of Post Marketing Surveillance and ADR Reporting \u003cbr\u003eCharacteristics of a Good Adverse Drug Reaction Report \u003cbr\u003ePeriodic Safety Update Report (PSUR) \u003cbr\u003eMedDRA or Medical Dictionary for Regulatory Activities \u003cbr\u003ePharmacovigilance in India \u003cbr\u003e\u003cbr\u003e\u003cb\u003eData and Safety Monitoring Board and Monitoring Plan\u003cbr\u003e\u003c\/b\u003eDefinition and Purpose \u003cbr\u003eData Monitoring Committee \u003cbr\u003eData Safety Monitoring Plan \u003cbr\u003e\u003cbr\u003e\u003cb\u003eStandard Operating Procedures\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eStandard Operating Procedures \u003cbr\u003eSOP Template \u003cbr\u003eMaster Formulation Record \u003cbr\u003e\u003cbr\u003e\u003cb\u003eArchiving Clinical Research Documents\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eStake Holders \u003cbr\u003eWhat Documents Must Be Archived \u003cbr\u003eHow long Should the Documents be Archived \u003cbr\u003eWhen to Archive Trail Master File (TMF) \u003cbr\u003eThe Archive Building\u003cbr\u003e\u003cbr\u003e\u003cb\u003eEvidence Based Medicine\u003cbr\u003e\u003c\/b\u003eIntroduction and Overview \u003cbr\u003eHistory \u003cbr\u003eTypes of EBM \u003cbr\u003eCategories of Evidence \u003cbr\u003eCategories of Recommendations \u003cbr\u003eStatistical Measures \u003cbr\u003eQuality of Clinical Trial Publications \u003cbr\u003eLimitations of Available Evidence \u003cbr\u003eCriticism of Evidence-Based Medicine \u003cbr\u003e\u003cbr\u003e\u003cb\u003eClinical Research Data Management\u003cbr\u003e\u003c\/b\u003eIntroduction \u003cbr\u003eProtocol \u003cbr\u003eRandomisation \u003cbr\u003eData Management \u003cbr\u003eFinal Study Report \u003cbr\u003eRetension and Securing of Records \u003cbr\u003eArchiving by the Principle Investigator \u003cbr\u003eArchiving by the Sponsor \u003cbr\u003e\u003cbr\u003e\u003cb\u003eClinical Biostatistics\u003cbr\u003e\u003c\/b\u003e(a) Biostatistics for Clinical Researcher\u003cbr\u003e26(a).1 Introduction\u003cbr\u003e26(a).2 Descriptive Statistics \u003cbr\u003e26(a).3 Null Hypothesis and Alternative Hypothesis \u003cbr\u003e26(a).4 Classifications of Data \u003cbr\u003e26(a).5 Test of 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