Pages: 248
Publisher: Chapman & Hall/CRC
Year of Publication: 2016
Author(s) : Jay Herson
Book Description:
Summary
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.
Features
• Presents useful table and graphical formats for data monitoring committees
• Emphasizes safety rather than efficacy
• Covers adaptive designs and the interpretation of tables
• Gives advice on how statisticians can best interact with physician members of these committees
• Covers new regulatory guidances on safety and the new responsibilities of DMCs
https://www.crcpress.com/Data-and-Safety-Monitoring-Committees-in-Clinical-Trials-Second-Edition/Herson/p/book/9781498784108
