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Innovation in Medical Evidence Development and Surveillance

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.

Dr. Janet Woodcock Discusses IMEDS