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Published on: August 12, 2014
The FDA Sentinel Real World Evidence Data Enterprise (RWE-DE)
Rishi J Desai1, Keith Marsolo2, Joshua Smith3
1Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
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.
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