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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, the author presents the statistical requirements of data monitoring committees and gives advice on how statisticians can best interact with physician members of these committees. He also shows how physicians think differently about safety data than statisticians, proving that both views are needed.

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Book Details

ISBN: 9781420070378
ISBN-10: 1420070371
Format: Hardback
(235mm x 156mm x 15mm)
Pages: 191
Imprint: Chapman & Hall/CRC
Publisher: Taylor & Francis Ltd
Publish Date: 26-Jan-2009
Country of Publication: United States

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Author Biography - Jay Herson

John Hopkins University, Baltimore, Maryland, USA Pfizer Research & Development, Kent, UK National Taiwan University, Taipei, Taiwan National Taiwan University, Taipei Duke University School of Medicine, Durham, North Carolina, Georgia Southern University, Statesboro, USA