Randomized clinical trials are the gold standard for establishing many clinical practice guidelines and are central to evidence based medicine. Obtaining the best evidence through clinical trials must be done within the boundaries of rigorous science and ethical principles. One fundamental principle is that trials should not continue longer than necessary to reach their objectives. Therefore, trials must be monitored for recruitment progress, quality of data, adherence to patient care or prevention standards, and early evidence of benefit or harm. Frequently, a group of external experts, independent from the investigators and trial sponsor, is charged with this monitoring responsibility, especially for safety and early benefit. This group is referred to by various names, such as a data monitoring committee or a data and safety monitoring board. This book, through a series of case studies presented by many distinguished clinical trial experts, illustrates the complexity of this monitoring process. The editors provide an overview of the process and a summary of a multitude of the lessons learned from the cases presented.

This book should be useful to anyone serving on a data and safety monitoring board, or planning to do so, for colleagues in academia, industry and governmental agencies, and for teaching students in biostatistics, epidemiology, clinical trials and medical ethics. No other text has as extensive a collection of cases which provide insight into the many issues, often conflicting, that must be examined before recommendations to continue or discontinue a trial can be made. While depth in statistical methods is not required, some familiarity with statistical design and analysis issues in clinical trials is helpful. The cases cover trials which were terminated early for convincing evidence of benefit, or for harmful effects. Cases with complex issues are also included. This series of cases should provide broad background information for potential monitoring committee members and better prepare them for the challenges that may exist in the trials for which they are responsible.

The three editors have contributed two overview chapters as well as several case studies to go along with cases contributed by a distinguished group of colleagues experienced in the design, monitoring and analysis of clinical trials. Dr. David DeMets is currently Professor and Chair, Department of Biostatistics and Medical Informatics at the University of Wisconsin-Madison. He is past president of the Eastern North American Region (ENAR) of the International Biometric Society, a past member of the Board of Directors of the American Statistical Association and an elected Fellow. He recently received the Robert Gordon Lectureship Award, given by the National Institutes of Health, for significant contributions to the field of clinical trials. Dr. Curt Furberg, is currently Professor (and former Chair) of the Department of Public Health Sciences at Wake Forest University. Previously, he was Head of the Clinical Trials Branch and Associate Director of the Clinical Applications and Prevention Program at the National Heart, Lung, and Blood Institute. Dr. Lawrence Friedman is a former Director of the Division of Epidemiology and Clinical Applications and a former Assistant Director for Ethics and Clinical Research at the National Heart, Lung, and Blood Institute. All three are past presidents of the Society of Clinical Trials. The editors have collaborated previously as coauthors of a text: the Fundamentals of Clinical Trials.

From the reviews:

"This book is a must-read for individuals serving on or supporting data monitoring committees as well as statisticians and other disciplines involved in the design and analysis of clinical trials with interim monitoring." Journal of Biopharmaceutical Sciences, Issue 6, 2006

"This edited book gives a brief introduction to data-monitoring committees for clinical trials ? . It has been my experience that many persons asked to serve on data-monitoring committees have scientific or clinical expertise relevant to the trial, but have little or no understanding of the purpose of the data-monitoring committee ? . Such individuals would greatly benefit from reading this book prior to serving on a data-monitoring committee, as would anyone wishing to gain some insight into the responsibilities and challenges facing data-monitoring committees." (S. W. Lagakos, Short Book Reviews, Vol. 26 (1), 2006)

"The chapters are clearly written, and the take-home lessons are apparent. The 70 contributing authors represent a full range of perspectives on data monitoring and give balanace to the exposition. ...In summary, the book achieves its goal and deserves a place in every medical school's library." (J. Wade Davis, Journal of the American Statistical Association, Vol. 102, No. 477, 2007)

"This book is highly recommended for anyone who starts to serve on a DMC or is already a member of such a board, and also for people in academia, industry, and regulatory agencies as well as for students in biostatistics, epidemiology, clinical trails, and medical ethics." Iris Pigeot, Biometrics, December 2006)

"This book illustrates the complexity of data monitoring processes through a series of case studies presented by many distinguished clinical trial experts. ? A total of 29 case studies have been discussed. ? This book would be quite useful for the researchers, investigators and individuals serving on the DMC, orplanning to do so, who would like to understand the application of data monitoring principles in clinical trials. I have thoroughly enjoyed reading this book and I think it has served its purpose ? ." (Faisel Yunus, Journal of Applied Statistics, Vol. 35 (5), 2007)