Data Monitoring Committees for Today and Tomorrow

This webinar will explore data monitoring committees (DMC) best practices that have emerged over the past 25 years. The emphasis will be on the safety monitoring responsibilities of DMCs in the pharma industry. The industry will be divided into Big Pharma, Middle Pharma and Infant Pharma.

The webinar will show how practices and issues vary over these three strata. From here organizational issues, meetings, clinical issues, useful statistical methods, biases and pitfalls, data monitoring committees decisions and emerging issues including adaptive designs, internal DMCs and cost control will be covered.

The impact of emerging Internet-based high tech vital signs and body fluid monitoring and automated risk based monitoring on DMC operations will also be covered. The issues are illustrated by actual behind-the-scenes scenarios providing a rare look at DMC practices.

Speaker

Dr. Jay Herson, Senior Associate, Biostatistics, Johns Hopkins University Baltimore, Maryland USA

Dr. Herson, a collaborator of IDDI, will draw on his 25-year experience with data monitoring committees (DMC) in the Pharmaceutical industry which led to his book Data and Safety Monitoring Committees in Clinical Trials published by Chapman and Hall/CRC in 2009.

Message Presenter