Data and Safety Monitoring Committees in Clinical Trials

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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. Leading you through the types of reports for adverse events and lab values ...

Data and Safety Monitoring Committees in Clinical Trials 2009, CRC Press, Boca Raton, FL

ISBN-13: 9781420070378

Hardcover

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