Data and Safety Monitoring Committees in Clinical Trials - Editio

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.

List of contents

Preface to the Second Edition. Introduction. Organization of a Safety Monitoring Program for a Confirmatory Trial. Meetings. Clinical Issues. Statistical Issues. Biases and Pitfalls. DMC Decisions. Emerging issues. Appendix.

About the author

Jay Herson is Senior Associate, Biostatistics, Johns Hopkins Bloomberg School of Public Health where he teaches courses on clinical trials and drug development based on his many years experience in clinical trials in academia and the pharmaceutical industry.

Product details

• Authors: Jay Herson, Jay (John Hopkins Bloomberg School of Publ Herson, Herson Jay
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Hardback
• Released: 13.12.2016
• EAN: 9781498784108
• ISBN: 978-1-4987-8410-8
• No. of pages: 266
• Series: Chapman & Hall/CRC Biostatistics Series
• Subjects: Natural sciences, medicine, IT, technology > Mathematics > Probability theory, stochastic theory, mathematical statistics; Epidemiology & medical statistics, MEDICAL / Biostatistics, MEDICAL / Research, MEDICAL / Epidemiology, Epidemiology and Medical statistics, Clinical Trials, DMCs;pharmaceutical trials;adaptive designs;drug safety