(316) The IMEDS Distributed Database Network and Pregnancy Studies

Background: Pregnant persons and other under-represented populations are often missing from clinical trials. Post-market requirements have become important vehicles to assess the safety and effectiveness of medical products during pregnancy and in diverse populations, but care must be taken to understand and limit potential bias when using real-world data.

The Innovation in Medical Evidence and Development Surveillance (IMEDS) program supports studies to fulfill post-market requirements for regulatory agencies. It also provides a framework for private-sector entities to leverage a subset of the FDA’s Sentinel Initiative. The Sentinel Initiative uses analytic tools to assess the safety of approved medical products. Network Partners’ (NP) data comprise the IMEDS Network, a real-world database expected to be representative of the commercially insured population in the US.

An important focus of IMEDS is advancing the use of real-world data for pregnancy. IMEDS recently had the unique opportunity to be one of the first to utilize Sentinel’s new tool to identify non-live births; and the IMEDS Network includes mother-infant linkage for live and non-live birth data.

Objectives: To describe the scope and scale of the IMEDS Network for conducting real-world pharmacoepidemiologic studies in pregnancy.

Methods: IMEDS data is characterized annually using a distributed framework approach. General demographics and pregnancy data are collected. General demographics are collected from seven of nine participating NPs, from January 2000 through July 2023, and pregnancy data are collected from three of the seven NPs.

Results: This IMEDS Network subset includes 124.72 million enrollment spans from 2000 to 2023. Approximately 83% of currently enrolled members are adults ( <18 years of age). Approximately 16% of members are White, 3% Black or African American, 1% are Asian, and 78% are unknown race. Approximately 13% are not Hispanic, 13% are Hispanic, and 86% have unknown ethnicity. Approximately 41% of IMEDS members live in the South, 22% live in the West, 14% in Northeast, and 24% in Midwest. Historically, 51% of members are female and 49% male. There are 4,465,047 total historical deliveries among women ages 10-54 years. In 2023, the linkage rate for live-birth pregnancies was 68%.

Conclusion: Through IMEDS Network, the private sector has access to a valuable real-world data resource to conduct pregnancy studies on approved medical products. Stakeholders who leverage the IMEDS Network benefit from a large cohort of pregnant women that is nationally representative of commercially insured persons, as well as IMEDS’ scientific expertise in this area and experience leveraging the FDA Sentinel tools. In our poster we will present approaches towards improving the mother-infant linkage, identification of non-live births, and capture of race and ethnicity.