Jay Herson

Data and Safety Monitoring Committees in Clinical Trials

• Gebundenes Buch

Produktbeschreibung

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.

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Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• 2nd edition
• Seitenzahl: 266
• Erscheinungstermin: 13. Dezember 2016
• Englisch
• Abmessung: 234mm x 156mm x 16mm
• Gewicht: 549g
• ISBN-13: 9781498784108
• ISBN-10: 1498784100
• Artikelnr.: 47330013

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.