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

View Abstract

PURPOSE

The US Food and Drug Administration's Sentinel Innovation Center aimed to establish a query-ready, quality-checked distributed data network containing electronic health records (EHRs) linked with insurance claims data for at least 10 million individuals to expand the utility of real-world data for regulatory decision-making.

METHODS

In this report, we describe the resulting network, the Real-World Evidence Data Enterprise (RWE-DE), including data from two commercial EHR-claims linked assets collectively termed the Commercial Network covering 21 million lives, and four academic partner institutions collectively termed the Development Network covering 4.5 million lives.

RESULTS

We discuss provenance and completeness of the data converted in the Sentinel Common Data Model (SCDM), describe patient populations, and report on EHR-claims linkage characterization for all contributing data sources. Further, we introduce a standardized process to store free-text notes in the Development Network for efficient retrieval as needed.

CONCLUSIONS

Finally, we outline typical use cases for the RWE-DE where it can broaden the reach of the types of questions that can be addressed by the Sentinel system.

Abbreviation
Pharmacoepidemiol Drug Saf
Publication Date
2024-10-11
Volume
33
Issue
10
Page Numbers
e70028
Pubmed ID
39385712
Medium
Print
Full Title
The FDA Sentinel Real World Evidence Data Enterprise (RWE-DE).
Authors
Desai RJ, Marsolo K, Smith J, Carrell D, Penfold R, Pillai HS, Lii J, Ngan K, Winter R, Adgent M, Ramaprasan A, Driscoll MR, Scarnecchia D, Kiernan D, Draper C, Lyons JG, Khurshid A, Maro JC, Zimmerman R, Brown J, Bright P, Hernández-Muñoz JJ, Matheny ME, Schneeweiss S