Description
Book SynopsisThe aim of this text is to provide the framework for building a clinical trial as it pertains to operative and non operative invasive procedures, how to get it funded and how to conduct such a trial up to publication of results
The text provides all details of building a scientifically and ethically valid proposal, including how to build the infrastructure for a clinical trial and how to move it forward through various funding agencies. The text also presents various types of clinical trials, the use of implantable devices and FDA requirements, and adjuncts to clinical trials and interaction with industry
Clinical Trials Design in Invasive Operative and Non Operative Procedures will be of interest to all specialists of surgery, anesthesiologists, interventional radiologists, gastroenterologists, cardiologists, and pulmonologists
Table of ContentsTable of Contents
Clinical Trials Design in Invasive Operative and Non Operative Procedures
Editors: Kamal M.F. Itani, Domenic J. Reda
Section I: Basic Principles
Ch. 1: The Research Question and the Hypothesis
Peter R. Nelson
Ch. 2: Primary and Secondary Endpoints Peter R. Nelson
Ch. 3: Intervention and Control Groups
Peter R. Nelson
Ch. 4: Subject Selection
Peter R. Nelson
Section II: Study Designs
Ch. 5: Clinical Phases of Device and Drug Evaluation with Emphasis on Early Phase Trials
Domenic J. Reda
Ch. 6: Overview of the Randomized Clinical Trial and the Parallel Group Design
Domenic J. Reda
Ch. 7: Non-Inferiority and Equivalence Trials
Domenic J. Reda
Ch. 8: Factorial Designs
Domenic J. Reda
Ch. 9: Cross-over Trials
Domenic J. Reda
Ch. 10: Cluster-Randomized Clinical Trials
William G. Hendreson
Ch. 11: Adaptive Trial Designs
Joshua S. Richman
Judy C. Boughey
<
Ch. 12: Pragmatic Trials
Ryan E. Ferguson
Louis Fiore
Ch. 13: Point of Care Clinical Trials
Mary T. Brophy
Ryan E. Ferguson
Statistical Considerations
Ch. 14: Basic Statistical Considerations
Eileen M. Stock
Kousick Biswas
Ch. 15: Methods and Timing of Randomization
Robert George Edson
Ch. 16: Sample Size Calculation
Eileen M. Stock
Kousick Biswas
Ch. 17: Principles of Analysis
Gary R. Johnson
Tassos C. Kyriakides
Ch. 18: Advanced Statistical Methods
Hui Wang
Ilana Belitskaya-Lévy
Mei-Chiung Shih
Ying Lu
Ch. 19: Missing Data
Kousick Biswas
Ch. 20: Interim Monitoring
Joseph F. Collins
Section IV: Ethical Considerations
Ch. 21: Ethical Considerations in Clinical Trials
Jennifer Tseng
Peter Angelos
Ch. 22: IRB and review process for multisite trials
Jennifer Tseng
Peter Angelos
Ch. 23: Trial advertising
Jennifer Tseng
Peter Angelos
Ch. 24: Payment to research participants
Jennifer Tseng
Peter Angelos
Ch. 25: Conflict of Interest
Jennifer Tseng
Peter Angelos
Section V: Considerations Specific to Surgical or Procedural Trials
Ch. 26: Quality Control in Procedural Studies Nicole E. Lopez
Lawrence T. Kim
Ch. 27: Pilot Studies
Ryan E. Ferguson
Mary T. Brophy
Ch. 28: Surgeon training and the learning curve
Kamal M.F. Itani
Ch. 29: Using a placebo or sham procedure as a control: ethics and practicalities
Joshua S. Richman
Ch. 30: Patient Recruitment and Retention in Procedural Trials
Drew Moghanaki
Tomer Z. Karas
Ch. 31: Equipoise in Interventional Trials
Judy C. Boughey
Section VI: Regulatory Considerations
Ch. 32: Setting up a clinical trial research office
Kamal M.F. Itani
Ch. 33: Regulatory Considerations: The Clinical Research Coordinator
Marie Campasano
Kamal M.F. Itani
Ch. 34: Data Collection Forms William G. Henderson
Marie Campasano
Ch. 35: Data Security
Jennifer M. Gabany
Kamal M.F. Itani
Ch. 36: Remote Monitoring of Data Quality
Jennifer M. Gabany
Ch. 37: Investigators meetings
Kamal M.F. Itani
Ch. 38: Site Visits
Kamal M.F. Itani
Ch. 39: Data Safety Monitoring Board: Composition and Role
Marco A. Zenati
William G. Henderson
Ch. 40: Endpoints committee
Leigh Neumayer William G. Henderson
Ch. 41: Regulatory Issues with Devices in Clinical Trials
Gregory Campbell
Ch. 42: Trial registration and public access to data
Shachar Laks
Lawrence T. Kim Yvonne Lucero
Section VII: Common Errors
Ch. 43: Mistakes in Clinical Trials<
William G. Henderson
Section VIII: Adjuncts to clinical trials
Ch. 44: Combined drugs and procedure trials
Ankur Kalra
Deepak L. Bhatt
Ch. 45: Genomics in Clinical Trials
Peter R. Nelson
Ch. 46: Biomarkers as Adjuncts to Clinical Trials
George Z. Li
Jiping Wang
Ch. 47: Patient-centered Designs (and Outcomes) Frances M. Weaver
Ch. 48: Economic Evaluations
Denise M. Hynes
Leigh Neumayer
Ch. 49: Telemedicine and mobile technology
<Thomas H. Shoultz
Heather L. Evans
Section IX: Budgeting
Ch. 50: Budgeting for a Clinical Trial
Eric L. Lazar
Section X: Funding
Ch. 51: Funding a Clinical Trial
Eric L. Lazar
Ch. 52: Writing Your Grant for the Patient Centered Outcomes Research Institute (PCORI)
Frances M. Weaver
Talar W. Markossian
Jennifer E. Layden
Ch. 53: Designing Clinical Trials for Quality and Impact: The Department of Veterans Affairs Approach to Developing a Cooperative Study
Grant D. Huang
Domenic J. Reda
Section XI: Publication
Ch. 54: Publication
J. Michael Gaziano
