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Fundamentals of Clinical Trials

  • Textbook
  • © 2010

Overview

Authors:
  1. Lawrence M. Friedman

    1. Rockville, USA

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    You can also search for this author in PubMed   Google Scholar

  2. Curt D. Furberg

    1. Division of Public Health Sciences, Wake Forest University School of Medicin, Winston-Salem, USA

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    You can also search for this author in PubMed   Google Scholar

  3. David L. DeMets

    1. Dept. Biostatistics & Medical Informatic, University of Wisconsin-Madison, Madison, USA

    View author publications

    You can also search for this author in PubMed   Google Scholar

  • Numerous examples of published clinical trials from a variety of medical disciples are used to meaningfully illustrate the fundamentals
  • Technical design issues such as sample size are considered but the technical details are kept to a minimum through the use of graphs and tables
  • The authors are active researchers leading clinical trials in broad areas, including cardiology, cancer, ophthalmology, diabetes, osteoporosis, AIDS, and women's health
  • Includes supplementary material: sn.pub/extras

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Table of contents (20 chapters)

  1. Front Matter

    Pages i-xviii
    Download chapter PDF

  2. Introduction to Clinical Trials

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 1-18

  3. Ethical Issues

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 19-36

  4. What Is the Question?

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 37-53

  5. Study Population

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 55-66

  6. Basic Study Design

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 67-96

  7. The Randomization Process

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 97-117

  8. Blindness

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 119-132

  9. Sample Size

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 133-167

  10. Baseline Assessment

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 169-182

  11. Recruitment of Study Participants

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 183-198

  12. Data Collection and Quality Control

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 199-214

  13. Assessing and Reporting Adverse Events

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 215-231

  14. Assessment of Health-Related Quality of Life

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 233-249

  15. Participant Adherence

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 251-268

  16. Survival Analysis

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 269-291

  17. Monitoring Response Variables

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 293-343

  18. Issues in Data Analysis

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 345-398

  19. Closeout

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 399-410

  20. Reporting and Interpreting of Results

    • Lawrence M. Friedman, Curt D. Furberg, David L. DeMets
    Pages 411-425
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Keywords

About this book

The clinical trial is “the most definitive tool for evaluation of the applicability of clinical research.” It represents “a key research activity with the potential to improve the quality of health care and control costs through careful comparison of alternative treatments” [1]. It has been called on many occasions, “the gold st- dard” against which all other clinical research is measured. Although many clinical trials are of high quality, a careful reader of the medical literature will notice that a large number have deficiencies in design, conduct, analysis, presentation, and/or interpretation of results. Improvements have occurred over the past few decades, but too many trials are still conducted without adequate attention to its fundamental principles. Certainly, numerous studies could have been upgraded if the authors had had a better understanding of the fundamentals. Since the publication of the first edition of this book, a large number of other texts on clinical trials have appeared, most of which are indicated here [2–21]. Several of them, however, discuss only specific issues involved in clinical trials. Additionally, many are no longer current. The purpose of this fourth edition is to update areas in which major progress has been made since the publication of the third edition. We have revised most chapters considerably and added one on ethical issues.

Reviews

From the reviews of the fourth edition:

“This book is clearly written for students in the arena of health care. Physicians and health care providers can use it as a reference book. … The organization and structure is good and logical. … it deepens the understanding of applications of statistical methods and the analysis of clinical trials. Also, it provides a list of references at the end of each chapter. … In summary, this is an important contribution, providing up-to-date coverage on clinical trial methodology in a logical and systematic manner.” (Technometrics, Vol. 53 (2), May, 2011)

Authors and Affiliations

  • Rockville, USA

    Lawrence M. Friedman

  • Division of Public Health Sciences, Wake Forest University School of Medicin, Winston-Salem, USA

    Curt D. Furberg

  • Dept. Biostatistics & Medical Informatic, University of Wisconsin-Madison, Madison, USA

    David L. DeMets

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