This course describes how Data Monitoring Committees (DMC’s) ensure the safety of clinical trials in the pharmaceutical industry. It explains appropriate statistical display and analysis methods for 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 data monitoring committee are discussed. The course is illustrated throughout with real-life examples.
Dr. Jay Herson
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.