Pharma Focus Asia

Data And Safety Monitoring Committees In Clinical Trials, Second Edition

Data And Safety Monitoring Committees In Clinical Trials, Second Edition

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

Latest Issue
Get instant
access to our latest e-book
MFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Gibco Adherent Kidney Media PanelCPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024ISPE Singapore Affiliate Conference & Exhibition 2024Rehab Expo 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024