Vision: A core goal of IMEDS is to support the FDA’s Sentinel System. IMEDS creates and fosters an inclusive environment that enhances continued engagement and participation by multiple stakeholders as Sentinel evolves. Accordingly, IMEDS is committed to ensuring the transparency of both process and findings. IMEDS serves to advance the science and tools necessary to support evidence generation on regulated products, including safety surveillance and evaluations, and to facilitate utilization of a robust electronic healthcare data platform for such activities.
By using the same data and tools, and by completing the same types of safety assessments as Sentinel used by FDA, IMEDS helps expand the volume and improve consistency of safety surveillance activities in the United States.
Governance and Collaborating Partners: IMEDS safety assessments will be completed by the IMEDS Operations Center (IOC) using the "IMEDS Distributed Database (IDD)".
The Pilot: The pilot was funded with two clear objectives:
- Phase I: Development of Policies and Procedures for the IMEDS-Evaluation Program
- Demonstration of the capabilities of the developing IMEDS- Evaluation program by utilizing existing, publicly available Mini-Sentinel summary table programs and modular programs to conduct two demonstration cases
Pfizer Pilot: Oral Contraceptives and VTE across the Sentinel data network - An IMEDS Evaluation Pilot assessment, ICPE, 2016.
Pfizer Pilot: Risk Minimization in a Distributed Data Network: An IMEDS Evaluation Pilot Assessment of the 2010 Class Label Change for Proton Pump Inhibitors, ICPE, 2016.
Progress: The IMEDS-Evaluation Pilot Project was completed early 2016. The final Policies and Procedures document has been approved by the Board Liaison Committee.
InquiriesPlease direct all inquiries to:
Christine Yu, IMEDS Program Coordinator
Reagan-Udall Foundation for the FDA