Data Monitoring Committees in Clinical Trials: A Practical Perspective / Edition 1

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The use of data monitoring committees within the pharmaceutical industry, often causes conflicts with clinical trials coordinators and uncertainty regarding regulatory compliance. This volume offers a practical approach to data monitoring.

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Editorial Reviews

From the Publisher
"…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) 

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Product Details

  • ISBN-13: 9780471489863
  • Publisher: Wiley
  • Publication date: 9/9/2002
  • Series: Statistics in Practice Series, #6
  • Edition number: 1
  • Pages: 208
  • Product dimensions: 6.28 (w) x 9.15 (h) x 0.66 (d)

Table of Contents


Responsibilities of the Data Monitoring Committee and Motivating Illustrations

Composition of a Data Monitoring Committee

Independence of the Data Monitoring Committee: Avoiding Conflicts of Interest

Confidentiality Issues Relating to the Data Monitoring Committee

Data Monitoring Committee Meetings

Data Monitoring Committee Interactions with Other Trial Components or Related Groups

Statistical, Philosophical and Ethical Issues in Data Monitoring

Determining When a Data Monitoring Committee Is Needed

Regulatory Considerations for the Operation of Data Monitoring Committees


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