Jay Herson's “Safety Monitoring Committees in Clinical Trials” describes how the safety of clinical trials in the pharmaceutical industry is assured through Data and Safety Monitoring Committees (DMC's):
Oct 23 - Nov 20: “Safety Monitoring Committees in Clinical Trials”
It covers the statistical display and analysis methods that are appropriate for the monitoring procedures, as well as the biases and pitfalls inherent in safety review. Emerging issues in the pharmaceutical industry and their effect on the activities of a safety monitoring committee are discussed. The course is illustrated throughout with real-life examples.
Dr. Jay Herson is currently serving on the adjunct faculty in Biostatistics at the Johns Hopkins Bloomberg School of Public health. His previous positions included Senior Biostatistician at the University of Texas MD Anderson Cancer Center and as president of the contract research organization he founded known as Applied Logic Associates. Under his leadership ALA grew from a solo consultancy to a 50-person full-service CRO with global capabilities. Dr. Herson started the first Data Monitoring Committee (DMC) in the pharmaceutical industry and has Chaired or served on 25 DMCs. He is author of numerous papers on statistical methodology and the book “Data and Safety Monitoring Committees in Clinical Trials”, published by Chapman and Hall/CRC Press, March, 2009. You can ask questions and exchange comments with Dr. Herson via a private discussion board throughout the period.
Details:
http://www.statistics.com/clinical-trials-monitoring
The course takes place online at Statistics.com in a series of 4 weekly lessons and assignments, and requires about 15 hours/week. Participate at your own convenience; there are no set times when you are required to be online.
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