The FDA Sentinel Real World Evidence Data Enterprise (RWE-DE)

Area of Science:

• Health Informatics
• Biomedical Data Science
• Regulatory Science

Background:

• The US Food and Drug Administration's Sentinel Initiative aims to leverage real-world data for regulatory purposes.
• Existing data infrastructure required expansion to accommodate diverse data sources and larger populations.

Purpose of the Study:

• To establish a query-ready, quality-checked distributed data network linking electronic health records (EHRs) with insurance claims data.
• To create a network encompassing at least 10 million individuals to enhance real-world data utility for regulatory decision-making.

Main Methods:

• Development of the Real-World Evidence Data Enterprise (RWE-DE) network.
• Integration of data from commercial EHR-claims linked assets (Commercial Network) and academic partner institutions (Development Network).
• Conversion of data into the Sentinel Common Data Model (SCDM), including characterization of patient populations and EHR-claims linkage.

Main Results:

• The RWE-DE network was established, comprising the Commercial Network (21 million lives) and the Development Network (4.5 million lives).
• Provenance, completeness, and linkage characteristics of the data within the SCDM were assessed.
• A standardized process for storing and retrieving free-text notes from the Development Network was implemented.

Conclusions:

• The RWE-DE network significantly expands the capacity and scope of the Sentinel system.
• The established network facilitates broader regulatory research questions by integrating diverse, large-scale real-world data.
• The RWE-DE enhances the utility of real-world evidence for informed regulatory decision-making.