Expert Workshop: Statistical and Epidemiological Issues in Active Medical Product Surveillance

The U.S. Food and Drug Administration (FDA) is developing the capacity for active medical product surveillance, which will enhance the agency’s ability to monitor the safety of marketed medical products. This new capacity will come in the form of the Sentinel System, which is currently being piloted through a project known as Mini-Sentinel. Accomplishing the goals of active medical product surveillance will require further development of new and existing methods and tools.

On February 16, the Engelberg Center for Health Care Reform hosted a one-day expert workshop to discuss some of the most pressing methodological issues facing active medical product safety surveillance. At this workshop, experts from academia, the private sector, FDA and other government agencies discussed several topics, including:

• Appropriate analysis and interpretation of signals in the context of large sample sizes
• Analyzing horizontally and vertically partitioned data
• Evaluating the performance of active surveillance methods