Live sessions will be held 8:30-noon, PT (11:30-3 p.m. ET) each day. Pre-recorded lectures, downloadable presentations, data sets and other course materials will be posted prior to the start of the module.

Over the past five decades as the role of the randomized clinical trial (RCT) has appropriately evolved to become the gold standard for evaluation of new drugs, biologics, devices, procedures and behavioral interventions, so has the role of the independent Data Monitoring Committee (DMC).  The DMC process was recommended by the Greenberg Report in 1967 to the National Heart, Lung and Blood Institute.

The mission of the DMC is to safeguard the interests of study participants and to enhance the integrity of clinical trials. Over the past four decades, the use of DMCs has spread across a very large number federal and industry sponsored clinical trials. Accompanying the growth of the use of DMCs has been the increased use of an independent Statistical Data Analysis Center (SDAC) that provides interim reports for the DMC. These reports allow the DMC to fulfill its mission by monitoring the progress of the RCT as well as reviewing periodically monitoring unblinded emerging efficacy and safety data. Based on review of the totality of this evidence, the DMC may recommend changes in the RCT or perhaps early termination if the data show evidence of harm or overwhelming evidence of benefit.

This course will review the rationale and role for the DMC, describe current best practices, and share some examples of DMC activity and recommendations for trial continuation or perhaps termination for overwhelming benefit, convincing evidence of harm, or likely futility in continuation.

Learning Objectives:

• Provide insight into the challenges of monitoring accumulating interim data for safety and efficacy
• Understanding the roles and practices of the DMC and the SDAC
• Understand the importance of the independence of the DMC for protecting the integrity of the RCT
• Understand interactions among the DMC, the independent SDAC and the trial sponsor
• Provide insights about and recommendations for Best Practices for DMCs and SDACs.

Course materials: To get the most out of this short course, participants are encouraged to acquire a copy of the 2nd edition, “Data Monitoring Committees in Clinical Trials: A Practical Perspective” by Susan Ellenberg, Thomas R. Fleming, and David L. DeMets, and have it on hand during the course. Note this 2nd edition released in 2019 has substantively enhanced insights relative to the 1st edition released in 2002.