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.
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.
If you have an idea for a research project, or are interested in learning how to leverage IMEDS as a resource for evidence generation, fill out this brief form to start the conversation.
IMEDS Network Partners (NP) include a subset of the Sentinel Distributed Data Network and contribute the data and scientific expertise IMEDS leverages to conduct Post Market Required (PMR) studies. The graphs below represent data from seven network partners from 2000 through their most recently available data as of October 2021. The recency of data varied across NPs, with the most recent data available ranging from December 2019 – October 2021. Queries were run using Sentinel distributed query tools.