Jay Herson

Data and Safety Monitoring Committees in Clinical Trials

• Broschiertes Buch

Produktbeschreibung

This book summarizes the author's experience in serving on many data monitoring committees 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 -sponsored trials.

Produktdetails

• Verlag: Chapman and Hall/CRC
• 2. Auflage
• Seitenzahl: 268
• Erscheinungstermin: 22. März 2019
• Englisch
• Abmessung: 234mm x 156mm x 15mm
• Gewicht: 412g
• ISBN-13: 9780367261276
• ISBN-10: 0367261278
• Artikelnr.: 56923505

Autorenporträt

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.

Inhaltsangabe

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.