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Clinical Trials Design in Operative and Non Operative Invasive Procedures

  • Kamal M.F. Itani
  • Domenic J. Reda

Table of contents

  1. Front Matter
    Pages i-xxiv
  2. Basic Principles

    1. Front Matter
      Pages 1-1
    2. Peter R. Nelson
      Pages 3-9
    3. Peter R. Nelson
      Pages 11-20
    4. Peter R. Nelson
      Pages 21-28
    5. Peter R. Nelson
      Pages 29-37
  3. Study Designs

    1. Front Matter
      Pages 39-39
    2. Domenic J. Reda
      Pages 59-68
    3. Domenic J. Reda
      Pages 69-77
    4. Domenic J. Reda
      Pages 79-86
    5. William G. Henderson
      Pages 87-97
    6. Joshua S. Richman, Judy C. Boughey
      Pages 99-107
    7. Ryan E. Ferguson, Louis Fiore
      Pages 109-114
    8. Mary T. Brophy, Ryan E. Ferguson
      Pages 115-122
  4. Statistical Considerations

    1. Front Matter
      Pages 123-123
    2. Eileen M. Stock, Kousick Biswas
      Pages 125-132
    3. Robert George Edson
      Pages 133-140
    4. Eileen M. Stock, Kousick Biswas
      Pages 141-150
    5. Gary R. Johnson, Tassos C. Kyriakides
      Pages 151-162
    6. Hui Wang, Ilana Belitskaya-Lévy, Mei-Chiung Shih, Ying Lu
      Pages 163-179
    7. Kousick Biswas
      Pages 181-188
    8. Joseph F. Collins
      Pages 189-196
  5. Ethical Considerations

    1. Front Matter
      Pages 197-197
    2. Jennifer Tseng, Peter Angelos
      Pages 199-203
    3. Jennifer Tseng, Peter Angelos
      Pages 205-207
    4. Jennifer Tseng, Peter Angelos
      Pages 209-210
    5. Jennifer Tseng, Peter Angelos
      Pages 211-213
    6. Jennifer Tseng, Peter Angelos
      Pages 215-217
  6. Considerations Specific to Surgical or Procedural Trials

    1. Front Matter
      Pages 219-219
    2. Nicole E. Lopez, Lawrence T. Kim
      Pages 221-234
    3. Ryan E. Ferguson, Mary T. Brophy
      Pages 235-244
    4. Kamal M. F. Itani
      Pages 245-250
    5. Drew Moghanaki, Tomer Z. Karas
      Pages 259-267
    6. Judy C. Boughey
      Pages 269-276
  7. Regulatory Considerations

    1. Front Matter
      Pages 277-277
    2. Kamal M. F. Itani
      Pages 279-284
    3. Marie Campasano, Kamal M. F. Itani
      Pages 285-292
    4. William G. Henderson, Marie Campasano
      Pages 293-302
    5. Jennifer M. Gabany, Kamal M. F. Itani
      Pages 303-311
    6. Jennifer M. Gabany
      Pages 313-318
    7. Kamal M. F. Itani
      Pages 319-322
    8. Kamal M. F. Itani
      Pages 323-328
    9. Marco A. Zenati, William G. Henderson
      Pages 329-334
    10. Leigh Neumayer, William G. Henderson
      Pages 335-339
    11. Gregory Campbell
      Pages 341-346
    12. Shachar Laks, Lawrence T. Kim, Yvonne Lucero
      Pages 347-354
  8. Common Errors

    1. Front Matter
      Pages 355-355

About this book

Introduction

 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

  • Kamal M.F. Itani
    • 1
  • Domenic J. Reda
    • 2
  1. 1.Department of SurgeryBoston VA Healthcare System Department of SurgeryWest RoxburyUSA
  2. 2.Depatment of Veteran Affairs, Cooperative Studies Program Coordinating CenterHines VA HospitalHinesUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-53877-8
  • Copyright Information Springer International Publishing AG 2017
  • Publisher Name Springer, Cham
  • eBook Packages Medicine
  • Print ISBN 978-3-319-53876-1
  • Online ISBN 978-3-319-53877-8
  • Buy this book on publisher's site