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.

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Policies and Procedures

IMEDS Distributed Network includes nine Network Partners (NP), with the majority of the IMEDS NPs overlaps with the Sentinel Distributed Data Network and contribute the data and scientific expertise IMEDS leverages to conduct real-world evidence projects including Post Market Required (PMR) studies. The graphs below represent data from seven network partners from 2000 through their most recently available data as of July 2023. The recency of data varied across NPs, with the most recent data available ranging from December 2021 – July 2023. Queries were run using Sentinel distributed query tools.

For more on IMEDS, watch our Introduction to Innovation in Medical Evidence and Development Surveillance (IMEDS): The Research Resource webinar here.

Patient Distribution IMEDS Network Geographic Region

This map shows the historic distribution of patients by geographic region from 2000-2023. Region is determined by their zip code on first day of their most recent enrollment span. Regions are based on the Health and Human Services (HHS) Region Descriptions. Data from Puerto Rico, Virgin Islands, American Samoa, Commonwealth of the Northern Mariana Islands, Federated States of Micronesia, Guam, Marshall Islands, and Republic of Palau are excluded from their respective HHS regions due to low cell counts.

Age Distribution Actively Enrolled Patients IMEDS Network

Age of active patients (as of the most recent data from our Network Partners in July 2023) is determined on the first day of their most recent enrollment span with both medical and drug coverage.

Sex Distribution of Actively Enrolled Patients IMEDS Network

This graph shows the historic distribution of sex in the IMEDS Network among those with medical and drug coverage in data pulled from 2000 to 2023.

Race Ethnicity Distribution of Patients in IMEDS Network

Historic distribution of race and ethnicity for patients that have at least one span of medical and drug coverage in data pulled from 2000 to 2023.

IMEDS Census by Year

The number of patients enrolled in the IMEDS Distributed Database over time spans from 2000-2023. Patients are counted if they have at least one day of medical coverage and one day of drug coverage within that year. Data in 2023 and possibly 2022 are likely to be incomplete because of varying end dates.

Distribution of Cumulative Follow-up of Patients in IMEDS Network

The distribution of cumulative enrollment with medical and drug coverage per patient within IMEDS Network covers over 105 million patients that have been enrolled for at least six months. An enrollment span is defined as having both medical and drug coverage. Cumulative enrollment is categorizing the total length of enrollment per patient, summing multiple enrollment spans if they exist. A single patient may contribute multiple enrollment spans to the IMEDS Network.

Length of Enrollment Spans in IMEDS Network

This graph shows the distribution of individual enrollment spans within the IMEDS Network. A single patient may contribute multiple enrollment spans to the IMEDS Network. Length of patient enrollment is categorizing the frequency of length of enrollment spans by enrollment record for patients with medical and drug coverage. An enrollment span is defined as having both medical and drug coverage. In this figure, gaps in coverage of less than 45 days are bridged into one enrollment span. The data visualization above shows 157M enrollment spans, which are derived from 125M patients.

Linked Deliveries IMEDS Network by Year

This graph shows the distribution of linked and unlinked deliveries over time in data pulled from 2000-2023 across three IMEDS Network Partners that contribute to the Sentinel Mother-Infant Linkage table. The data reflects live births only. Data in 2023 and possibly 2022 are likely to be incomplete because of varying end dates.

Mothers and infants are matched mainly on family subscriber numbers and, when available, birth certificate data. Most matches were deterministic, though probabilistic matching methods were also used by some Network Partners. More information about the MIL table may be found in the Mother-Infant Linkage FAQ (link: https://www.sentinelinitiative.org/sites/default/files/data/distributed-database/MIL_FAQs&Appendice…).

Sentinel's algorithm for determining linkage with an infant requires an assignment of an infant patient identifier within the first year of life. Potential linkages are discarded if an infant patient identifier is not assigned within one year of the linkage date.

Linked Deliveries Mothers Age

This graph shows the distribution of linked and unlinked deliveries by mother’s age group. The IMEDS Distributed Network contains 9,411 linked deliveries among 45-54-year-olds, 3.28 million among 20-44-year-olds, and around 147,761 among 10-19-year-olds across three IMEDS Network Partners. It is more common for mothers in the 45-54 years group to have different healthcare plans than their infants, leading to challenges in linkage. The data reflects live births only in data pulled from 2000 to 2023.