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Clinical Trials Design in Operative and Non Operative Invasive Procedures


Clinical Trials Design in Operative and Non Operative Invasive Procedures



von: Kamal M.F. Itani, Domenic J. Reda

178,49 €

Verlag: Springer
Format: PDF
Veröffentl.: 16.05.2017
ISBN/EAN: 9783319538778
Sprache: englisch

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Beschreibungen

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 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

 

 

Kamal MF Itani MDVABHCS(112A)1400 VFW ParkwayWest Roxbury, MA 02132Domenic Reda PhDHines CSP Coordinating Center5000 South 5th AvenueHines, IL 60141Kamal 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.
 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.
Provides the framework for building a clinical trial as it pertains to operative and non operative invasive proceduresWritten by experts in the fieldProvides details of building a scientifically and ethically valid proposal

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