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

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There has been substantial growth in the use of data monitoring committees in recent years, by both government agencies and the pharmaceutical industry. This growth has been brought about by increasing recognition of the value of such committees in safeguarding trial participants as well as protecting trial integrity and the validity of conclusions. This very timely book describes the operation of data monitoring committees, and provides an authoritative guide to their establishment, purpose and responsibilities.
* Provides a practical overview of data monitoring in clinical trials.
* Describes the purpose, responsibilities and operation of data monitoring committees.
* Provides directly applicable advice for those managing and conducting clinical trials, and those serving on data monitoring committees.
* Gives insight into clinical data monitoring to those sitting on regulatory and ethical committees.
* Discusses issues pertinent to those working in clinical trials in both the US and Europe.
The practical guidance provided by this book will be of use to professionals working in and/or managing clinical trials, in academic, government and industry settings, particularly medical statisticians, clinicians, trial co-ordinators, and those working in regulatory affairs and bioethics.

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

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.

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