Innovation in Medical Evidence Development and Surveillance (IMEDS) is a program within the Reagan-Udall Foundation for the FDA, a public private partnership, that aims to address several critical needs including continued development of methods for using electronic health data for safety assessments and broader purposes; establishing a long-term, research agenda and corresponding governance structure to address methodological needs of Sentinel and other stakeholders; leveraging the Sentinel tools to help answer other important questions about the safety and effectiveness of interventions; and training new scientists and equipping them with the knowledge and expertise to conduct safety assessments.
IMEDS will help the FDA, regulated industry and clinicians improve patient care and the safety of medical products by focusing on three areas.
- IMEDS-Methods: Supports the development of a methods research agenda and coordination of methods research in support of using electronic health data for safety surveillance conducted by FDA as well as the broader community of researchers.
- IMEDS-Education: Offers educational opportunities in areas related to medical product safety surveillance, and methods research and application for scientific professionals.
- IMEDS-Evaluation: Applies Methods and Education lessons learned for medical product assessments to facilitate leveraging Sentinel tools and capabilities toward a national resource for evidence generation.