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

Susan S. Ellenberg (Author), Thomas R. Fleming (Author), David L. DeMets (Author)

Book Description

Publication Date: September 9, 2002 | ISBN-10: 0471489867 | ISBN-13: 978-0471489863 | Edition: 1

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.

Editorial Reviews

Review

"…essential reading for anyone establishing, joining or interacting with data monitoring committees…" (Journal of Clinical Research Practices, September 2007)

"...meets an important need...of interest to the broad spectrum of individuals ivolved in clinical trials..." (Controlled Clinical Trials)

"This wonderful addition to Wiley's 'Statistics in Practice' series is the definitive how-to-do-it manual for running a DMC.." (IRB: Ethics & Human Research , January/February 2003)

"…This is the sort of book that RECs need access to for reference…" (Bulletin of Medical Ethics, February 2003)

"…an excellent starting point …for anyone involved in setting up a data monitoring committee for a clinical trial…" (Short Book Reviews, April 2003)

"…an extremely useful addition…highly recommended…" (Statistical Methods in Medical Research, Vol.12, No.2, 2003)

"...highly recommended, perhaps even required, for those on DMC's...a book well written. I recommend it for library purchase." (The Statistician)

"......clearly required reading for scientists working on clinical trials..." (Good Clinical Practice Journal, Dec 2003)

"...would recommend it to any statistician in the pharmaceutical industry who has any dealing with DMCs..." (Pharmaceutical Statistics, Vol 2, 2003)

"There is very little to criticize about this book…[it] is well written, addressing philosophical, statistical and practical issues…" (Statistics in Medicine, 2004; 23)

“…well organized…invites the reader to go on…” (Statistical Methods in Medical Research, No.13 2004) 

From the Back Cover

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.

Product Details

• Hardcover: 208 pages
• Publisher: Wiley; 1 edition (September 9, 2002)
• Language: English
• ISBN-10: 0471489867
• ISBN-13: 978-0471489863
• Product Dimensions: 9.3 x 6.3 x 0.6 inches
• Shipping Weight: 1.1 pounds (View shipping rates and policies)
• Average Customer Review: 4.5 out of 5 stars  See all reviews (2 customer reviews)
• Amazon Best Sellers Rank: #750,607 in Books (See Top 100 in Books)

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Most Helpful Customer Reviews

30 of 30 people found the following review helpful:

5.0 out of 5 stars data monitoring described by the experts, February 19, 2008

By 

Michael R. Chernick "statman31147" (Holland PA) - See all my reviews
(REAL NAME)   

This review is from: Data Monitoring Committees in Clinical Trials: A Practical Perspective (Statistics in Practice) (Hardcover)

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.

7 of 7 people found the following review helpful:

4.0 out of 5 stars Excellent Guide, December 26, 2006

By 

R. Albin (Ann Arbor, Michigan United States) - See all my reviews
(TOP 500 REVIEWER)    (REAL NAME)   

This review is from: Data Monitoring Committees in Clinical Trials: A Practical Perspective (Statistics in Practice) (Hardcover)

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.