Data and Safety Monitoring Committees in Clinical Trials- 1st ed (2009) Pdf Free Download

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This is a book about best practices in safety monitoring through data monitoring committees (DMCs) in pharmaceutical industry clinical trials. It will be useful for those who have served on DMCs, those interested in what was done well and what could have been done better, and those contemplating serving on their first committee.

I can still remember that winter morning in San Antonio twenty years ago when Frank Rockhold asked me at a biostatistical meeting we were attending if I could organize a DMC for a gastrointestinal drug his company was developing. Frank, his talented colleagues, and I worked out a plan and the first DMC in pharmaceutical industry trials was born. At the time I headed a contract research organization (CRO) in Houston known as Applied Logic Associates (ALA). Since then that company has provided statistical support to more than 50 DMCs and I have served as statistical member on DMCs for about 30 additional trials. The art and science of safety monitoring through DMCs have reached adolescence and it is time to review, and perhaps debate, best practices. There can be no better time than now, when regulatory agencies worldwide are facing considerable challenges in drug safety for both premarket and postmarketed drugs.

In the world of drug development, clinical issues and statistical issues cannot be separated. All issues are scientific. All use applied logic. This is the approach to this book. It is written in the style of my “Herson’s Handout” column that appeared in the ALA newsletter Under the Curve, 1991–2004. This was a style appropriate for all drug development professionals regardless of degrees held. The book assumes that the reader has a basic knowledge of clinical trials, clinical operations, and good clinical practices.

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