Fundamentals of Clinical Trials

  • Lawrence M. Friedman
  • Curt D. Furberg
  • David L. DeMets

Table of contents

  1. Front Matter
    Pages i-xviii
  2. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 1-18
  3. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 19-36
  4. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 37-53
  5. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 55-66
  6. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 67-96
  7. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 97-117
  8. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 119-132
  9. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 133-167
  10. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 169-182
  11. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 183-198
  12. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 199-214
  13. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 215-231
  14. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 233-249
  15. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 251-268
  16. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 269-291
  17. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 293-343
  18. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 345-398
  19. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 399-410
  20. Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 411-425

About this book

Introduction

This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added and topics such as noninferiority and adaptive designs now receive considerable discussion. There is much new material on adverse events, adherence, data monitoring, and issues in analysis. 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 from a variety of medical disciplines 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

AIDS Clinical Trials Diabetes Statistical Models Survival analysis assessment cancer data analysis disease prevention prevention

Authors and affiliations

  • Lawrence M. Friedman
    • 1
  • Curt D. Furberg
    • 2
  • David L. DeMets
    • 3
  1. 1.RockvilleUSA
  2. 2.Division of Public Health SciencesWake Forest University School of MedicinWinston-SalemUSA
  3. 3.Dept. Biostatistics & Medical InformaticUniversity of Wisconsin-MadisonMadisonUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-1-4419-1586-3
  • Copyright Information Springer New York 2010
  • Publisher Name Springer, New York, NY
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-1-4419-1585-6
  • Online ISBN 978-1-4419-1586-3
  • About this book