The 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 Contents Clinical Trials Design in Invasive Operative and Non Operative Procedures Editors: Kamal M.F. Itani, Domenic J. Reda Section I: Basic PrinciplesCh. 1: The Research Question and the Hypothesis Peter R. NelsonCh. 2: Primary and Secondary EndpointsPeter R. NelsonCh. 3: Intervention and Control GroupsPeter R. NelsonCh. 4: Subject SelectionPeter R. NelsonSection II: Study DesignsCh. 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 DesignDomenic J. RedaCh. 7: Non-Inferiority and Equivalence Trials Domenic J. RedaCh. 8: Factorial DesignsDomenic J. RedaCh. 9: Cross-over Trials Domenic J. RedaCh. 10: Cluster-Randomized Clinical Trials William G. HendresonCh. 11: Adaptive Trial Designs Joshua S. RichmanJudy C. Boughey <Ch. 12: Pragmatic Trials Ryan E. FergusonLouis F
ioreCh. 13: Point of Care Clinical Trials Mary T. BrophyRyan E. Ferguson Statistical ConsiderationsCh. 14: Basic Statistical Considerations Eileen M. StockKousick BiswasCh. 15: Methods and Timing of Randomization Robert George EdsonCh. 16: Sample Size Calculation Eileen M. StockKousick BiswasCh. 17: Principles of Analysis Gary R. JohnsonTassos C. KyriakidesCh. 18: Advanced Statistical Methods Hui WangIlana Belitskaya-LévyMei-Chiung ShihYing LuCh. 19: Missing Data Kousick BiswasCh. 20: Interim Monitoring Joseph F. CollinsSection IV: Ethical ConsiderationsCh. 21: Ethical Considerations in Clinical Trials Jennifer TsengPeter AngelosCh. 22: IRB and review process for multisite trials Jennifer TsengPeter AngelosCh. 23: Trial advertising Jennifer TsengPeter AngelosCh. 24: Payment to research participants Jennifer TsengPeter AngelosCh. 25: Conflict of Interest Jennifer Tseng
Peter AngelosSection V: Considerations Specific to Surgical or Procedural TrialsCh. 26: Quality Control in Procedural Studies Nicole E. LopezLawrence T. KimCh. 27: Pilot Studies Ryan E. FergusonMary T. BrophyCh. 28: Surgeon training and the learning curve Kamal M.F. ItaniCh. 29: Using a placebo or sham procedure as a control: ethics and practicalities Joshua S. RichmanCh. 30: Patient Recruitment and Retention in Procedural Trials Drew MoghanakiTomer Z. KarasCh. 31: Equipoise in Interventional Trials Judy C. BougheySection VI: Regulatory ConsiderationsCh. 32: Setting up a clinical trial research office Kamal M.F. ItaniCh. 33: Regulatory Considerations: The Clinical Research Coordinator Marie CampasanoKamal M.F. ItaniCh. 34: Data Collection Forms William G. HendersonMarie CampasanoCh. 35: Data Security Jennifer M. GabanyKamal M.F. ItaniCh. 36: Remote Monitoring of Data Quality Jennifer M. Gaba
nyCh. 37: Investigators meetings Kamal M.F. ItaniCh. 38: Site Visits Kamal M.F. ItaniCh. 39: Data Safety Monitoring Board: Composition and Role Marco A. ZenatiWilliam G. HendersonCh. 40: Endpoints committee Leigh NeumayerWilliam G. HendersonCh. 41: Regulatory Issues with Devices in Clinical Trials Gregory CampbellCh. 42: Trial registration and public access to data Shachar LaksLawrence T. KimYvonne LuceroSection VII: Common ErrorsCh. 43: Mistakes in Clinical Trials William G. HendersonSection VIII: Adjuncts to clinical trialsCh. 44: Combined drugs and procedure trials Ankur KalraDeepak L. BhattCh. 45: Genomics in Clinical Trials Peter R. NelsonCh. 46: Biomarkers as Adjuncts to Clinic
The Research Question and the Hypothesis.- Primary and Secondary Endpoints.- Intervention and Control Groups.- Subject Selection.- Clinical Phases of Device and Drug Evaluation with Emphasis on Early Phase Trials.- Overview of Randomized Clinical Trial and the Parallel Group Design.- Non-Inferiority and Equivalence Trials.- Factorial Designs.- Cross-over Trials.- Cluster-Randomized Clinical Trials.- Adaptive Trial Designs.- Pragmatic Trials.- Point of Care Clinical Trials.- Basic Statistical Considerations.- Methods and Testing of Randomization.- Sample Size Calculation.- Principles of Analysis.- Advanced Statistical Methods.- Missing Data.- Interim Monitoring.- Ethical Considerations in Clinical Trials.- IRB and Review Process for Multisite Trials.- Trial Advertising.- Payment to Research Participants.- Conflict of Interest.- Quality Control in Procedural Studies.- Pilot Studies.- Surgeon Training and the Learning Curve.- Using a Placebo or Sham Procedure as a Control: Ethics and Practicalities.- Patient Recruitment and Retention in Procedural Trials.- Equipoise in Interventional Trials.- Setting up a Clinical Trial Research Office.- Regulatory Considerations: The Clinical Research Coordinator.- Data Collection Forms.- Data Security.- Remote Monitoring of Data Quality.- Investigators Meetings.- Site Visits.- Data Safety Monitoring Board: Composition and Role.- Endpoints Committee.- Regulatory Issues with Devices in Clinical Trials.- Trial Registration and Public Access to Data.- Mistakes in Clinical Trials.- Combined Drugs and Procedure Trials.- Genomics in Clinical Trials.- Biomarkers as Adjuncts to Clinical Trials.- Patient-centered Designs (and Outcomes).- Economic Evaluations.- Telemedicine and Mobile Technology.- Budgeting for a Clinical Trial.- Funding a Clinical Trial.- Writing Your Grant for the Patient Centered Outcomes Research Institute (PCORI).- Designing Clinical Trials for Quality and Impact: The Department of Veterans Affairs Approach to Developing aCooperative Study.- Publication.
Kamal MF Itani MDVABHCS(112A)1400 VFW ParkwayWest Roxbury, MA 02132 Domenic Reda PhDHines CSP Coordinating Center5000 South 5th AvenueHines, IL 60141 Kamal M. F. Itani, MD, Chief of surgery at the VA Boston Health Care System is a Professor of Surgery at Boston University. Dr Itani attended medical school at the American University of Beirut, residency in surgery at Baylor College of Medicine and a research fellowship in the Department of Surgery at Duke University. Prior to his move to Boston, Dr. Itani was an Associate Professor in the Michael E. DeBakey Department of Surgery and The Assistant Dean for Graduate Medical Education at Baylor College of Medicine. He was also Chief of General Surgery at the Houston VA Medical Center and a staff surgeon at The Ben Taub General Hospital.
Dr. Itanis primary clinical interest is in surgical infections, hernia repair and surgical education with a research focus on the improvement of health services and surgical outcomes within his areas of clinical interest. He is the author or co-author of more than 150 peer-reviewed journal articles, editorials, and book chapters and is the lead investigator on several clinical trials. Dr Itani is a member of various surgical organizations and has served in various leadership positions in these organizations. He currently sits on several National committees including the VA Surgical quality improvement project (VASQIP), the research committee of the American College of Surgeons, and chairs the surgical quality data use group (SQDUG), the research arm of VASQIP. He is also the course director for the American College of Surgeons clinical trials course since 2007. He is a member of the editorial board of the American Journal of Surgery, Surgical Infection, Hospital Physician, and is a reviewer for several medical and surgical journals. In addition to his various leadership roles in various surgical associations and societies, he is past President of The Association of VA Surgeons.
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