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Data Monitoring Committees in Clinical Trials: A Practical Perspective (Statistics in Practice)

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Susan Ellenberg is a Professor of Biostatistics at the University of Pennsylvania. Prior to that she played a prominent role in the development of statistical methods for clinical trials at the US Food and Drug Administration. She made major contributions to the Harmonization Committee's ICH Guidelines on statistical methods in clinical trials, particularly the Guideline E9.

Tom Fleming and David DeMets are Professor of Biostatistics at University of Washington and Wisconsin University respectively. They are among the world's leading experts in group sequential methods. Fleming is famous for the O'Brien-Fleming stopping rule that bears his name and DeMets is known for the Lan-DeMets alpha spending function approach to group sequential analysis.

With such experts and excellent writers you get what you should expec t, an authoritative treatment of the practical and technical aspects of the monitoring of data by Data Monitoring Committees (DMCs, previously called Data Safety and Monitoring Boards, DMSBs). These committees look at interim data from a clinical trial to judge whether the trial should be stopped early for safety concerns. In their charter they can set-up their own rule or can debate and make subjective decisions. These authors through their experience present examples and also formal statistical methods that can be used not only to stop for safety concerns but also to stop if safety and efficacy are demonstrated earlier than anticipated in the design. Also if the trial is clearly going to be unsuccessful they can stop for futility as well.

The development of group sequential methods and adaptive designs make a formal analysis for the DMC possible. For a detailed account of group sequential methods see the book by Jennison and Turnbull. For adaptive designs the two books by Mark Chang (one co-authored with Professor Chow) are excellent. Another excellent book similar to this text is the text by Proschan, Lan and Wittes which covers the theory and applications more than the aspects of the DMC.

All or almost all significant clinical trials involve Data Monitoring Committees (DMCs; also known as Data Safety and Monitoring Committees; DSMBs). These bodies provide independent oversight of the safety and operation of clinical trials. This book is a well organized and clearly written discussion of the operation of DMCs/DSMBs. Very practically oriented, the book discusses virtually all aspects of DMCs/DSMBs from their rationale to the nuts and bolts of running committee meetings. In addition to being comprehensive, this book is distinguished by the liberal and appropriate use of numerous concrete examples to illustrate many of the issues that come up in the operation of a DMC/DSMB. This book should be read and owned by anyone serving on a DMC/DSMB. Anyone heavily involved in clinical trials should be familiar with the contents of this book.