Designs for Clinical Trials

Perspectives on Current Issues

  • DavidĀ Harrington

Table of contents

  1. Front Matter
    Pages i-xiv
  2. Ying Kuen Cheung
    Pages 1-27
  3. KyungMann Kim
    Pages 57-79
  4. Jay Herson, Marc Buyse, Janet Turk Wittes
    Pages 109-137
  5. Stephen L. George, Xiaofei Wang
    Pages 157-177
  6. Back Matter
    Pages 199-204

About this book


Statistical methods for clinical trials have been an area of active research in Biostatistics since the first modern clinical trials were mounted in 1946 by the British Medical Research Council in whooping cough and tuberculosis.  Often, the participants in clinical trials suffer from potentially fatal chronic diseases, and it is especially important that these experiments in medical research use designs that are efficient, can be understood by physicians, policy makers and patients, respond quickly new ideas in medicine and statistics, and, perhaps above all, show respect for the complex and important ethical issues that arise in these settings.


This book explores some recent thinking in designs for clinical trials, including alternative designs for phase I studies, interim monitoring for futility, adaptive designs based on accumulating outcome data, and designs of new, targeted therapies.  The book is intended for both the statistical practitioner, who may be too busy to stay abreast of the literature on statistical methods, as well as statisticians conducting research in clinical trials.


HIV prevention trials adaptive designs cancer clinical trials correlative genomic studies randomization algorithms

Editors and affiliations

  • DavidĀ Harrington
    • 1
  1. 1.Dana-Farber Cancer InstituteHarvard Medical SchoolBostonUSA

Bibliographic information