IMEDS- Methods Research Agenda

Section 905 of the Food and Drug Administration Amendments Act (FDAAA) mandates FDA to develop an enhanced ability to monitor the safety of drugs after these products reach the market. In response to this mandate, FDA launched its Sentinel Initiative, a long-term program designed to build and implement an electronic system for monitoring the safety of medical products in the post market setting. FDA has already created significant infrastructure on which to operate such a system: through its Mini-Sentinel pilot, a distributed database with access to more than 150 million patient records has been created (the Sentinel Distributed Database). In order to optimally leverage these data, however, new analytic methodologies will be required. IMEDS-Methods is a program within the Reagan-Udall Foundation (RUF) that supports the FDA's scientific mission of serving public health needs by initiating and facilitating research into the methods of safety evaluation in large databases. IMEDS-Methods aims to improve the tools for conducting post-marketing safety surveillance using automated healthcare data and to foster their adoption. Research Objectives IMEDS plans to conduct methods research in five core areas: (1) addressing bias in estimates from observational studies; (2) better understanding uses and limitations of the data; (3) applying lessons learned from earlier IMEDS projects to FDA surveillance activities; (4) expanding the surveillance question to continuous Risk/Benefit assessment; and (5) continuing to support qualified investigators in industry, government, and academic settings by providing access to de-identified electronic healthcare data and computing resources through the IMEDS Research Laboratory.