The Reagan-Udall Foundation has formed a public-private partnership to provide access for private-sector entities, such as regulated industry, academic institutions, and non-profit organizations, to a system based on the Food and Drug Administration’s (FDA) Sentinel Initiative. This collaboration works with selected Sentinel data partners and the Harvard Pilgrim Healthcare Institute, functioning as the Analytic or Coordinating Center, to facilitate the analyses of medical product safety evaluations.
The FDA encourages the leveraging of Sentinel capabilities through the Innovation in Medical Evidence and Development Surveillance (IMEDS) program as a national resource for broader public health and medical evidence generation. Besides surveillance activities, the IMEDS distributed database can be used for population characterization and effectiveness studies. IMEDS projects must be scientifically suitable for use by the database and should address a safety concern of public health interest. Examples are exposures to medical products, exposure-outcome relationships, or impact of risk mitigation activities. All research findings undertaken by IMEDS will be released in the public domain after project completion.
Benefits of using IMEDS include the large volume of patient data available and the reliability of an established network. It affords users the ability to gain direct experience with FDA’s post-market assessment safety methods and tools that have proven and replicable results. Because the baseline infrastructure already exists, evaluation analyses can be completed timely and efficiently with operations based on transparency. Most importantly, the collaborative partnership with public and private sector entities including healthcare payors, academic institutions, pharmaceutical companies and the FDA all contribute to collective knowledge building around real world evidence generation.
The Reagan-Udall Foundation provides educational opportunities to learn more about how to use the IMEDS database to answer important post-market research questions. Please contact us directly at IMEDS@reaganudall.org for more information.
Network Partners and Steering Committee
The IMEDS Network is currently comprised of nine Network Partners, including national and regional health systems and insurers in the US. The IMEDS Network includes healthcare data on ~110 million people, including children, pregnant women, Medicare and Medicaid populations, since approximately 2006. The primary data available for research include demographic and administrative claims for visits, procedures, laboratory and pharmacy encounters (e.g. ICD-9/10, CPT, NDC, HCPCS codes). Medical records are (potentially) available for approximately 80% of the population.
Comprised of experts from across the field, the IMEDS Steering Committee provides programmatic oversight and operational guidance. Meet the IMEDS Steering Committee.
- FDA Foundation's Director of Research Carla Rodriguez-Watson, PhD, co-authored the manuscript "The use of narrative electronic prescribing instructions in pharmacoepidemiology: A scoping review for the International Society for Pharmacoepidemiology" published in Pharmacoepidemiology & Drug Safety. The manuscript focuses on narrative electronic prescribing instructions (NEPI), text which provides information from a prescriber about the administration of a medication. The paper evaluates how NEPIs are used in research, the challenges and opportunities for their broader application, and recommendations for their wider use. Read more
- Saama's "Active Surveillance: A New Paradigm in Patient Safety" webinar featuring Carla Rodriguez-Watson, PhD, MPH, IMEDS Scientific Director
- Nominations Open for IMEDS Steering Committee
- CDER's 2018 Drug Safety Priorities Report features IMEDS
- published in the New England Journal of Medicine, Platt, R, Brown, J., Robb, M., McClellan, M., Ball, R., Nguyen, M., and Sherman, R., The FDA Sentinel Initiative--An Evolving National Resource, 379;22, 2091-2, Copyright © (2018) Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
- Sequential surveillance for drug safety in a regulatory environment discusses IMEDS methods research in Pharmacoepidemiology and Drug Safety, March 2018
- Introducing IMEDS, a Public-Private Resource for Evidence Generation by Dr. Robert Califf in FDA Voices, January 2017
- FDA Touts EvGen, IMEDS Programs Ensuring Patient Safety in Med Device Online, January 2017
Find more journal articles on IMEDS studies in our Research Portfolio
Learn More about IMEDS
- IMEDS Brochure
- 2018 DIA Interview discussing how IMEDS helps answer drug safety and other pharmacovigilance questions