The FDA Sentinel Real World Evidence Data Enterprise (RWE-DE).
EHR
FDA
RWE
RWE‐DE
Sentinel
data infrastructure
free text notes
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
Oct 2024
Oct 2024
Historique:
received:
06
09
2024
accepted:
16
09
2024
medline:
10
10
2024
pubmed:
10
10
2024
entrez:
10
10
2024
Statut:
ppublish
Résumé
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. 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. 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. 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.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e70028Subventions
Organisme : FDA HHS
ID : 75F40119D10037
Pays : United States
Informations de copyright
© 2024 John Wiley & Sons Ltd.
Références
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