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Fundamentals of Clinical Trials

  • Textbook
  • © 2010


  • 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:

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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 Additionally, many are no longer current.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.

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Table of contents (20 chapters)


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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