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Data and Safety Monitoring Committees in Clinical Trials

Data and Safety Monitoring Committees in Clinical Trials

Hardcover

Series: Chapman & Hall/CRC Biostatistics

Medical ReferenceProbability & Statistics

ISBN10: 1498784100
ISBN13: 9781498784108
Publisher: CRC Press
Published: Dec 13 2016
Pages: 266
Weight: 1.21
Height: 0.63 Width: 6.14 Depth: 9.21
Language: English

Focusing on the practical clinical and statistical issues that arise in pharmaceutical industry trials, this book summarizes the author's experience in serving on many data monitoring committees (DMCs) and in heading up a contract research organization that provided statistical support to nearly seventy-five DMCs. It explains the difference in DMC operations between the pharmaceutical industry and National Institutes of Health (NIH)-sponsored trials.

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