Clinical Trials Design in Operative and Non Operative Invasive Procedures

Editors: Itani, Kamal M.F., Reda, Domenic (Eds.)

  • Provides the framework for building a clinical trial as it pertains to operative and non operative invasive procedures
  • Written by experts in the field
  • Provides details of building a scientifically and ethically valid proposal
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Buy this book

eBook $149.00
price for USA (gross)
  • ISBN 978-3-319-53877-8
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $199.00
price for USA
valid through November 5, 2017
  • ISBN 978-3-319-53876-1
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
About this book

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

About the authors

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.

Table of contents (54 chapters)

  • The Research Question and the Hypothesis

    Nelson, Peter R.

    Pages 3-9

  • Primary and Secondary Endpoints

    Nelson, Peter R.

    Pages 11-20

  • Intervention and Control Groups

    Nelson, Peter R.

    Pages 21-28

  • Subject Selection

    Nelson, Peter R.

    Pages 29-37

  • Clinical Phases of Device and Drug Evaluation with Emphasis on Early Phase Trials

    Reda, Domenic J.

    Pages 41-50

Buy this book

eBook $149.00
price for USA (gross)
  • ISBN 978-3-319-53877-8
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover $199.00
price for USA
valid through November 5, 2017
  • ISBN 978-3-319-53876-1
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
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Bibliographic Information

Bibliographic Information
Book Title
Clinical Trials Design in Operative and Non Operative Invasive Procedures
Editors
  • Kamal M.F. Itani
  • Domenic Reda
Copyright
2017
Publisher
Springer International Publishing
Copyright Holder
Springer International Publishing AG
eBook ISBN
978-3-319-53877-8
DOI
10.1007/978-3-319-53877-8
Hardcover ISBN
978-3-319-53876-1
Edition Number
1
Number of Pages
XXIV, 495
Number of Illustrations and Tables
15 b/w illustrations, 27 illustrations in colour
Topics