Table 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
About the Author: 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. Itani's 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.
