IMEDS-Evaluation

IMEDS-Evaluation Program

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 IOC, managed by and located at RUF, leads all scientific and management operations of IMEDS. It is the central point of contact for all collaborating partners, and manages and coordinates the administrative and project management aspects of the IMEDS Program.
  • The IMEDS Director provides scientific and operational leadership for the IMEDS program in general. For specific sponsored projects, the IMEDS Director serves as either lead or co-lead. The IMEDS Director reports to the RUF Executive Director, and oversees the IMEDS program.
  • The IMEDS Board Liaison Committee, IMEDS Steering Committee, and IMEDS Scientific Advisory Committee provide strategic guidance to the IOC on the mission and vision, scientific guidance, and oversight of the various partnerships IMEDS forms. These governing bodies are comprised of stakeholders from regulated industry, data partners, providers, academia, patient and consumer advocates, and FDA.
  • IMEDS Data Analytic Center (IDAC), currently the Harvard Pilgrim Healthcare Institute, provides data coordinating services, results reporting, and report generation services for IMEDS sponsored projects. The IDAC provides Sentinel tools and procedures to facilitate the use of the IMEDS Distributed Database in a manner which mirrors FDA’s use of Sentinel. It also works with the IOC and Sponsor to develop protocol based or other customized assessments for IMEDS Sponsor Projects.
  • IMEDS Data Partners includes organizations that are fully operational Sentinel Data Partners, with an operational SDD. The IMEDS Data Partners must pass the most recent data quality checking algorithms established within Sentinel.
  • The Pilot: The pilot was funded with two clear objectives:

    1. Phase I: Development of Policies and Procedures for the IMEDS-Evaluation Program
    2. 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

    Publications/Presentations
    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.


    Inquiries

    Please direct all inquiries to:

    Christine Yu, IMEDS Program Coordinator
    Reagan-Udall Foundation for the FDA
    Email: IMEDS@reaganudall.org