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  • Book
  • © 2017

Clinical Trials Design in Operative and Non Operative Invasive Procedures

Editors:

(view affiliations)
  • 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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eBook
USD 149.00
Price excludes VAT (USA)
  • ISBN: 978-3-319-53877-8
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Softcover Book
USD 199.99
Price excludes VAT (USA)
Hardcover Book
USD 199.99
Price excludes VAT (USA)

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Table of contents (54 chapters)

  1. Front Matter

    Pages i-xxiv
  2. Basic Principles

    1. Front Matter

      Pages 1-1
    2. The Research Question and the Hypothesis

      • Peter R. Nelson
      Pages 3-9
    3. Primary and Secondary Endpoints

      • Peter R. Nelson
      Pages 11-20
    4. Intervention and Control Groups

      • Peter R. Nelson
      Pages 21-28
    5. Subject Selection

      • Peter R. Nelson
      Pages 29-37
  3. Study Designs

    1. Front Matter

      Pages 39-39
    2. Non-inferiority and Equivalence Trials

      • Domenic J. Reda
      Pages 59-68
    3. Factorial Designs

      • Domenic J. Reda
      Pages 69-77
    4. Cross-over Trials

      • Domenic J. Reda
      Pages 79-86
    5. Cluster Randomized Clinical Trials

      • William G. Henderson
      Pages 87-97
    6. Adaptive Trial Designs

      • Joshua S. Richman, Judy C. Boughey
      Pages 99-107
    7. Pragmatic Trials

      • Ryan E. Ferguson, Louis Fiore
      Pages 109-114
    8. Point-of-Care Clinical Trials

      • Mary T. Brophy, Ryan E. Ferguson
      Pages 115-122
  4. Statistical Considerations

    1. Front Matter

      Pages 123-123
    2. Basic Statistical Considerations

      • Eileen M. Stock, Kousick Biswas
      Pages 125-132
    3. Methods and Timing of Randomization

      • Robert George Edson
      Pages 133-140
    4. Sample Size Calculation

      • Eileen M. Stock, Kousick Biswas
      Pages 141-150

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.

Keywords

  • Pragmatic Trials
  • Ethical Considerations
  • Procedural Trials
  • Devices and FDA
  • Writing Your Grant

Editors and Affiliations

  • Department of Surgery, Boston VA Healthcare System Department of Surgery, West Roxbury, USA

    Kamal M.F. Itani

  • Depatment of Veteran Affairs, Cooperative Studies Program Coordinating Center, Hines VA Hospital, Hines, USA

    Domenic J. Reda

About the editors

Kamal MF Itani MD
VABHCS(112A)
1400 VFW Parkway
West Roxbury, MA 02132

Domenic Reda PhD
Hines CSP Coordinating Center
5000 South 5th Avenue
Hines, 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.

Bibliographic Information

  • Book Title: Clinical Trials Design in Operative and Non Operative Invasive Procedures

  • Editors: Kamal M.F. Itani, Domenic J. Reda

  • DOI: https://doi.org/10.1007/978-3-319-53877-8

  • Publisher: Springer Cham

  • eBook Packages: Medicine, Medicine (R0)

  • Copyright Information: Springer International Publishing AG 2017

  • Hardcover ISBN: 978-3-319-53876-1

  • Softcover ISBN: 978-3-319-85263-8

  • eBook ISBN: 978-3-319-53877-8

  • Edition Number: 1

  • Number of Pages: XXIV, 495

  • Number of Illustrations: 15 b/w illustrations, 27 illustrations in colour

  • Topics: General Surgery, Anesthesiology, Interventional Radiology, Cardiology

  • Industry Sectors: Biotechnology, Health & Hospitals, Pharma

Buying options

eBook
USD 149.00
Price excludes VAT (USA)
  • ISBN: 978-3-319-53877-8
  • Instant PDF download
  • Readable on all devices
  • Own it forever
  • Exclusive offer for individuals only
  • Tax calculation will be finalised during checkout
Softcover Book
USD 199.99
Price excludes VAT (USA)
Hardcover Book
USD 199.99
Price excludes VAT (USA)