Fundamentals of Clinical Trials

  • Lawrence M. Friedman
  • Curt D. Furberg
  • David L. DeMets
  • David M. Reboussin
  • Christopher B. Granger

Table of contents

  1. Front Matter
    Pages i-xxi
  2. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 1-23
  3. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 25-48
  4. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 49-71
  5. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 73-88
  6. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 89-121
  7. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 123-145
  8. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 147-163
  9. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 165-200
  10. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 201-214
  11. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 215-232
  12. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 233-253
  13. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger, Thomas J. Moore
    Pages 255-277
  14. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger, Michelle J. Naughton et al.
    Pages 279-295
  15. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 297-318
  16. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 319-341
  17. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 343-372
  18. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 373-401
  19. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 403-462
  20. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets, David M. Reboussin, Christopher B. Granger
    Pages 463-477

About this book

Introduction

This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. 

This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals.

The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives.

Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful.  This book has been successfully used for teaching courses in clinical trial methodology.  

Keywords

Clinical Researcher Clinical Trial Methodology Clinical Trials Medical Reference Randomization Regulatory Issues in Clinical Trials Sample Size Statistical Models

Authors and affiliations

  • Lawrence M. Friedman
    • 1
  • Curt D. Furberg
    • 2
  • David L. DeMets
    • 3
  • David M. Reboussin
    • 4
  • Christopher B. Granger
    • 5
  1. 1.North BethesdaUSA
  2. 2.Division of Public Health SciencesWake Forest School of MedicineWinston-SalemUSA
  3. 3.Dept. Biostatistics & Medical InformaticsUniversity of WisconsinMadisonUSA
  4. 4.Department of BiostatisticsWake Forest School of MedicineWinston-SalemUSA
  5. 5.Department of MedicineDuke UniversityDurhamUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-18539-2
  • Copyright Information Springer International Publishing Switzerland 2015
  • Publisher Name Springer, Cham
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-3-319-18538-5
  • Online ISBN 978-3-319-18539-2
  • About this book