{"product_id":"clinical-trials-9781118959206","title":"Clinical Trials","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eThis Third Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003ePreface to the Third Edition xxv\u003c\/p\u003e \u003cp\u003eAbout the Companion Website xxviii\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Preliminaries 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1.1 Introduction 1\u003c\/p\u003e \u003cp\u003e1.2 Audiences 2\u003c\/p\u003e \u003cp\u003e1.3 Scope 3\u003c\/p\u003e \u003cp\u003e1.4 Other Sources of Knowledge 5\u003c\/p\u003e \u003cp\u003e1.5 Notation and Terminology 6\u003c\/p\u003e \u003cp\u003e1.6 Examples, Data, and Programs 9\u003c\/p\u003e \u003cp\u003e1.7 Summary 9\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Clinical Trials as Research 10\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 10\u003c\/p\u003e \u003cp\u003e2.2 Research 13\u003c\/p\u003e \u003cp\u003e2.3 Defining Clinical Trials 19\u003c\/p\u003e \u003cp\u003e2.4 Practicalities of Usage 29\u003c\/p\u003e \u003cp\u003e2.5 Nonexperimental Designs 35\u003c\/p\u003e \u003cp\u003e2.6 Summary 41\u003c\/p\u003e \u003cp\u003e2.7 Questions for Discussion 41\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Why Clinical Trials are Ethical 43\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 43\u003c\/p\u003e \u003cp\u003e3.2 Duality 47\u003c\/p\u003e \u003cp\u003e3.3 Historically Derived Principles of Ethics 57\u003c\/p\u003e \u003cp\u003e3.4 Contemporary Foundational Principles 65\u003c\/p\u003e \u003cp\u003e3.5 Methodologic Reflections 72\u003c\/p\u003e \u003cp\u003e3.6 Professional Conduct 79\u003c\/p\u003e \u003cp\u003e3.7 Summary 85\u003c\/p\u003e \u003cp\u003e3.8 Questions for Discussion 86\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Contexts for Clinical Trials 87\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 87\u003c\/p\u003e \u003cp\u003e4.2 Drugs 91\u003c\/p\u003e \u003cp\u003e4.3 Devices 95\u003c\/p\u003e \u003cp\u003e4.4 Prevention 99\u003c\/p\u003e \u003cp\u003e4.5 Complementary and Alternative Medicine 106\u003c\/p\u003e \u003cp\u003e4.6 Surgery and Skill-Dependent Therapies 116\u003c\/p\u003e \u003cp\u003e4.7 A Brief View of Some Other Contexts 130\u003c\/p\u003e \u003cp\u003e4.8 Summary 135\u003c\/p\u003e \u003cp\u003e4.9 Questions for Discussion 136\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Measurement 137\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 137\u003c\/p\u003e \u003cp\u003e5.2 Objectives 140\u003c\/p\u003e \u003cp\u003e5.3 Measurement Design 143\u003c\/p\u003e \u003cp\u003e5.4 Surrogate Outcomes 162\u003c\/p\u003e \u003cp\u003e5.5 Summary 170\u003c\/p\u003e \u003cp\u003e5.6 Questions for Discussion 171\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 Random Error and Bias 172\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 172\u003c\/p\u003e \u003cp\u003e6.2 Clinical Bias 181\u003c\/p\u003e \u003cp\u003e6.3 Statistical Bias 188\u003c\/p\u003e \u003cp\u003e6.4 Summary 194\u003c\/p\u003e \u003cp\u003e6.5 Questions for Discussion 194\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 Statistical Perspectives 196\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 196\u003c\/p\u003e \u003cp\u003e7.2 Differences in Statistical Perspectives 197\u003c\/p\u003e \u003cp\u003e7.3 Frequentist 202\u003c\/p\u003e \u003cp\u003e7.4 Bayesian 204\u003c\/p\u003e \u003cp\u003e7.5 Likelihood 210\u003c\/p\u003e \u003cp\u003e7.6 Statistics Issues 212\u003c\/p\u003e \u003cp\u003e7.7 Summary 215\u003c\/p\u003e \u003cp\u003e7.8 Questions for Discussion 216\u003c\/p\u003e \u003cp\u003e\u003cb\u003e8 Experiment Design in Clinical Trials 217\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e8.1 Introduction 217\u003c\/p\u003e \u003cp\u003e8.2 Trials As Simple Experiment Designs 218\u003c\/p\u003e \u003cp\u003e8.3 Goals of Experiment Design 223\u003c\/p\u003e \u003cp\u003e8.4 Design Concepts 225\u003c\/p\u003e \u003cp\u003e8.5 Design Features 230\u003c\/p\u003e \u003cp\u003e8.6 Special Design Issues 237\u003c\/p\u003e \u003cp\u003e8.7 Importance of the Protocol Document 244\u003c\/p\u003e \u003cp\u003e8.8 Summary 252\u003c\/p\u003e \u003cp\u003e8.9 Questions for Discussion 253\u003c\/p\u003e \u003cp\u003e\u003cb\u003e9 The Trial Cohort 254\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e9.1 Introduction 254\u003c\/p\u003e \u003cp\u003e9.2 Cohort Definition and Selection 255\u003c\/p\u003e \u003cp\u003e9.3 Modeling Accrual 264\u003c\/p\u003e \u003cp\u003e9.4 Inclusiveness, Representation, and Interactions 267\u003c\/p\u003e \u003cp\u003e9.5 Summary 275\u003c\/p\u003e \u003cp\u003e9.6 Questions for Discussion 275\u003c\/p\u003e \u003cp\u003e\u003cb\u003e10 Development Paradigms 277\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e10.1 Introduction 277\u003c\/p\u003e \u003cp\u003e10.2 Pipeline Principles and Problems 281\u003c\/p\u003e \u003cp\u003e10.3 A Simple Quantitative Pipeline 286\u003c\/p\u003e \u003cp\u003e10.4 Late Failures 292\u003c\/p\u003e \u003cp\u003e10.5 Summary 300\u003c\/p\u003e \u003cp\u003e10.6 Questions for Discussion 301\u003c\/p\u003e \u003cp\u003e\u003cb\u003e11 Translational Clinical Trials 302\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e11.1 Introduction 302\u003c\/p\u003e \u003cp\u003e11.2 Inferential Paradigms 308\u003c\/p\u003e \u003cp\u003e11.3 Evidence and Theory 312\u003c\/p\u003e \u003cp\u003e11.4 Translational Trials Defined 313\u003c\/p\u003e \u003cp\u003e11.5 Information From Translational Trials 317\u003c\/p\u003e \u003cp\u003e11.5.6 Sample Size for Translational Trials 324\u003c\/p\u003e \u003cp\u003e11.5.7 Validity 327\u003c\/p\u003e \u003cp\u003e11.6 Summary 328\u003c\/p\u003e \u003cp\u003e11.7 Questions for Discussion 328\u003c\/p\u003e \u003cp\u003e\u003cb\u003e12 Early Development and Dose-Finding 329\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12.1 Introduction 329\u003c\/p\u003e \u003cp\u003e12.2 Basic Concepts 330\u003c\/p\u003e \u003cp\u003e12.3 Essential Concepts for Dose versus Risk 333\u003c\/p\u003e \u003cp\u003e12.4 Dose-Ranging 338\u003c\/p\u003e \u003cp\u003e12.5 Dose-Finding is Model Based 344\u003c\/p\u003e \u003cp\u003e12.6 General Dose-Finding Issues 354\u003c\/p\u003e \u003cp\u003e12.7 Summary 366\u003c\/p\u003e \u003cp\u003e12.8 Questions for Discussion 368\u003c\/p\u003e \u003cp\u003e\u003cb\u003e13 Middle Development 370\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13.1 Introduction 370\u003c\/p\u003e \u003cp\u003e13.2 Characteristics of Middle Development 372\u003c\/p\u003e \u003cp\u003e13.3 Design Issues 375\u003c\/p\u003e \u003cp\u003e13.4 Middle Development Distills True Positives 379\u003c\/p\u003e \u003cp\u003e13.5 Futility and Nonsuperiority Designs 381\u003c\/p\u003e \u003cp\u003e13.6 Dose–Efficacy Questions 385\u003c\/p\u003e \u003cp\u003e13.7 Randomized Comparisons 386\u003c\/p\u003e \u003cp\u003e13.8 Cohort Mixtures 392\u003c\/p\u003e \u003cp\u003e13.9 Summary 395\u003c\/p\u003e \u003cp\u003e13.10 Questions for Discussion 396\u003c\/p\u003e \u003cp\u003e\u003cb\u003e14 Comparative Trials 397\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14.1 Introduction 397\u003c\/p\u003e \u003cp\u003e14.2 Elements of Reliability 398\u003c\/p\u003e \u003cp\u003e14.3 Biomarker-Based Comparative Designs 402\u003c\/p\u003e \u003cp\u003e14.4 Some Special Comparative Designs 408\u003c\/p\u003e \u003cp\u003e14.5 Summary 411\u003c\/p\u003e \u003cp\u003e14.6 Questions for Discussion 412\u003c\/p\u003e \u003cp\u003e\u003cb\u003e15 Adaptive Design Features 413\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e15.1 Introduction 413\u003c\/p\u003e \u003cp\u003e15.2 Some Familiar Adaptations 418\u003c\/p\u003e \u003cp\u003e15.3 Biomarker Adaptive Trials 423\u003c\/p\u003e \u003cp\u003e15.4 Re-Designs 425\u003c\/p\u003e \u003cp\u003e15.5 Seamless Designs 427\u003c\/p\u003e \u003cp\u003e15.6 Barriers to the Use of AD 428\u003c\/p\u003e \u003cp\u003e15.7 Adaptive Design Case Study 428\u003c\/p\u003e \u003cp\u003e15.8 Summary 429\u003c\/p\u003e \u003cp\u003e15.9 Questions for Discussion 429\u003c\/p\u003e \u003cp\u003e\u003cb\u003e16 Sample Size and Power 430\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e16.1 Introduction 430\u003c\/p\u003e \u003cp\u003e16.2 Principles 431\u003c\/p\u003e \u003cp\u003e16.3 Early Developmental Trials 436\u003c\/p\u003e \u003cp\u003e16.4 Simple Estimation Designs 438\u003c\/p\u003e \u003cp\u003e16.5 Event Rates 451\u003c\/p\u003e \u003cp\u003e16.6 Staged Studies 455\u003c\/p\u003e \u003cp\u003e16.7 Comparative Trials 457\u003c\/p\u003e \u003cp\u003e16.8 Expanded Safety Trials 478\u003c\/p\u003e \u003cp\u003e16.9 Other Considerations 481\u003c\/p\u003e \u003cp\u003e16.10 Summary 489\u003c\/p\u003e \u003cp\u003e16.11 Questions for Discussion 490\u003c\/p\u003e \u003cp\u003e\u003cb\u003e17 Treatment Allocation 492\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e17.1 Introduction 492\u003c\/p\u003e \u003cp\u003e17.2 Randomization 494\u003c\/p\u003e \u003cp\u003e17.3 Constrained Randomization 500\u003c\/p\u003e \u003cp\u003e17.4 Adaptive Allocation 504\u003c\/p\u003e \u003cp\u003e17.5 Other Issues Regarding Randomization 507\u003c\/p\u003e \u003cp\u003e17.6 Unequal Treatment Allocation 514\u003c\/p\u003e \u003cp\u003e17.7 Randomization Before Consent 519\u003c\/p\u003e \u003cp\u003e17.8 Summary 520\u003c\/p\u003e \u003cp\u003e17.9 Questions for Discussion 520\u003c\/p\u003e \u003cp\u003e\u003cb\u003e18 Treatment Effects Monitoring 522\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e18.1 Introduction 522\u003c\/p\u003e \u003cp\u003e18.2 Administrative Issues in Trial Monitoring 527\u003c\/p\u003e \u003cp\u003e18.3 Organizational Issues Related to Monitoring 537\u003c\/p\u003e \u003cp\u003e18.4 Statistical Methods for Monitoring 545\u003c\/p\u003e \u003cp\u003e18.5 Summary 570\u003c\/p\u003e \u003cp\u003e18.6 Questions for Discussion 572\u003c\/p\u003e \u003cp\u003e\u003cb\u003e19 Counting Subjects and Events 573\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e19.1 Introduction 573\u003c\/p\u003e \u003cp\u003e19.2 Imperfection and Validity 574\u003c\/p\u003e \u003cp\u003e19.3 Treatment Nonadherence 575\u003c\/p\u003e \u003cp\u003e19.4 Protocol Nonadherence 580\u003c\/p\u003e \u003cp\u003e19.5 Data Imperfections 583\u003c\/p\u003e \u003cp\u003e19.6 Summary 588\u003c\/p\u003e \u003cp\u003e19.7 Questions for Discussion 589\u003c\/p\u003e \u003cp\u003e\u003cb\u003e20 Estimating Clinical Effects 590\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e20.1 Introduction 590\u003c\/p\u003e \u003cp\u003e20.2 Dose-Finding and Pharmacokinetic Trials 594\u003c\/p\u003e \u003cp\u003e20.3 Middle Development Studies 599\u003c\/p\u003e \u003cp\u003e20.4 Randomized Comparative Trials 606\u003c\/p\u003e \u003cp\u003e20.5 Problems With \u003ci\u003eP\u003c\/i\u003e-Values 616\u003c\/p\u003e \u003cp\u003e20.6 Strength of Evidence Through Support Intervals 620\u003c\/p\u003e \u003cp\u003e20.7 Special Methods of Analysis 622\u003c\/p\u003e \u003cp\u003e20.8 Exploratory Analyses 628\u003c\/p\u003e \u003cp\u003e20.9 Summary 639\u003c\/p\u003e \u003cp\u003e20.10 Questions for Discussion 640\u003c\/p\u003e \u003cp\u003e\u003cb\u003e21 Prognostic Factor Analyses 644\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e21.1 Introduction 644\u003c\/p\u003e \u003cp\u003e21.2 Model-Based Methods 647\u003c\/p\u003e \u003cp\u003e21.3 Adjusted Analyses of Comparative Trials 661\u003c\/p\u003e \u003cp\u003e21.4 PFAS Without Models 666\u003c\/p\u003e \u003cp\u003e21.5 Summary 669\u003c\/p\u003e \u003cp\u003e21.6 Questions for Discussion 669\u003c\/p\u003e \u003cp\u003e\u003cb\u003e22 Factorial Designs 671\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e22.1 Introduction 671\u003c\/p\u003e \u003cp\u003e22.2 Characteristics of Factorial Designs 672\u003c\/p\u003e \u003cp\u003e22.3 Treatment Interactions 675\u003c\/p\u003e \u003cp\u003e22.4 Examples of Factorial Designs 680\u003c\/p\u003e \u003cp\u003e22.5 Partial Fractional and Incomplete Factorials 682\u003c\/p\u003e \u003cp\u003e22.6 Summary 683\u003c\/p\u003e \u003cp\u003e22.7 Questions for Discussion 683\u003c\/p\u003e \u003cp\u003e\u003cb\u003e23 Crossover Designs 684\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e23.1 Introduction 684\u003c\/p\u003e \u003cp\u003e23.2 Advantages and Disadvantages 686\u003c\/p\u003e \u003cp\u003e23.3 Analysis 691\u003c\/p\u003e \u003cp\u003e23.4 Classic Case Study 696\u003c\/p\u003e \u003cp\u003e23.5 Summary 696\u003c\/p\u003e \u003cp\u003e23.6 Questions for Discussion 697\u003c\/p\u003e \u003cp\u003e\u003cb\u003e24 Meta-Analyses 698\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e24.1 Introduction 698\u003c\/p\u003e \u003cp\u003e24.2 A Sketch of Meta-Analysis Methods 700\u003c\/p\u003e \u003cp\u003e24.3 Other Issues 705\u003c\/p\u003e \u003cp\u003e24.4 Summary 707\u003c\/p\u003e \u003cp\u003e24.5 Questions for Discussion 708\u003c\/p\u003e \u003cp\u003e\u003cb\u003e25 Reporting and Authorship 709\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e25.1 Introduction 709\u003c\/p\u003e \u003cp\u003e25.2 General Issues in Reporting 710\u003c\/p\u003e \u003cp\u003e25.3 Clinical Trial Reports 715\u003c\/p\u003e \u003cp\u003e25.4 Authorship 726\u003c\/p\u003e \u003cp\u003e25.5 Other Issues in Disseminating Results 731\u003c\/p\u003e \u003cp\u003e25.6 Summary 732\u003c\/p\u003e \u003cp\u003e25.7 Questions for Discussion 733\u003c\/p\u003e \u003cp\u003e\u003cb\u003e26 Misconduct and Fraud in Clinical Research 734\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e26.1 Introduction 734\u003c\/p\u003e \u003cp\u003e26.2 Research Practices 741\u003c\/p\u003e \u003cp\u003e26.3 Approach to Allegations of Misconduct 743\u003c\/p\u003e \u003cp\u003e26.4 Characteristics of Some Misconduct Cases 747\u003c\/p\u003e \u003cp\u003e26.5 Lessons 754\u003c\/p\u003e \u003cp\u003e26.6 Clinical Investigators’ Responsibilities 757\u003c\/p\u003e \u003cp\u003e26.7 Summary 759\u003c\/p\u003e \u003cp\u003e26.8 Questions for Discussion 760\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix A Data and Programs 761\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eA.1 Introduction 761\u003c\/p\u003e \u003cp\u003eA.2 Design Programs 761\u003c\/p\u003e \u003cp\u003eA.3 \u003ci\u003eMathematica \u003c\/i\u003eCode 763\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix B Abbreviations 764\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix C Notation and Terminology 769\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eC.1 Introduction 769\u003c\/p\u003e \u003cp\u003eC.2 Notation 769\u003c\/p\u003e \u003cp\u003eC.3 Terminology and Concepts 772\u003c\/p\u003e \u003cp\u003e\u003cb\u003eAppendix D Nuremberg Code 788\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eD.1 Permissible Medical Experiments 788\u003c\/p\u003e \u003cp\u003eReferences 790\u003c\/p\u003e \u003cp\u003eIndex 871\u003c\/p\u003e","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":48738355446103,"sku":"9781118959206","price":122.4,"currency_code":"GBP","in_stock":false}],"url":"https:\/\/bookcurl.com\/products\/clinical-trials-9781118959206","provider":"Book Curl","version":"1.0","type":"link"}