Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Oct;33(10):e70028.
doi: 10.1002/pds.70028.

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

Rishi J Desai  1 , Keith Marsolo  2 , Joshua Smith  3 , David Carrell  4 , Robert Penfold  4 , Haritha S Pillai  1 , Joyce Lii  1 , Kerry Ngan  1 , Robert Winter  3 , Margaret Adgent  5 , Arvind Ramaprasan  4 , Meighan Rogers Driscoll  6 , Daniel Scarnecchia  6 , Daniel Kiernan  6 , Christine Draper  6 , Jennifer G Lyons  6 , Anjum Khurshid  6 , Judith C Maro  6 , Ruth Zimmerman  7 , Jeffrey Brown  8 , Patricia Bright  9 , José J Hernández-Muñoz  9 , Michael E Matheny  3   10 , Sebastian Schneeweiss  1
Affiliations

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

Rishi J Desai et al. Pharmacoepidemiol Drug Saf. 2024 Oct.

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.

Keywords: EHR; FDA; RWE; RWE‐DE; Sentinel; data infrastructure; free text notes.

PubMed Disclaimer

References

    1. R. Ball, M. Robb, S. Anderson, and G. Dal Pan, “The FDA's Sentinel Initiative—A Comprehensive Approach to Medical Product Surveillance,” Clinical Pharmacology & Therapeutics 99, no. 3 (2016): 265–268.
    1. R. Platt, J. S. Brown, M. Robb, et al., “The FDA Sentinel Initiative—An Evolving National Resource,” New England Journal of Medicine 379, no. 22 (2018): 2091–2093.
    1. J. C. Maro, M. D. Nguyen, J. Kolonoski, et al., “Six Years of the US Food and Drug Administration's Postmarket Active Risk Identification and Analysis System in the Sentinel Initiative: Implications for Real World Evidence Generation,” Clinical Pharmacology & Therapeutics 114 (2023): 815–824.
    1. Sentinel Distributed Database (SDD), “Statistics Summary: 2000–2023,” (2023), https://www.sentinelinitiative.org/about/key‐database‐statistics.
    1. K. J. Lin, R. J. Glynn, D. E. Singer, S. N. Murphy, J. Lii, and S. Schneeweiss, “Out‐of‐System Care and Recording of Patient Characteristics Critical for Comparative Effectiveness Research,” Epidemiology (Cambridge, Mass) 29, no. 3 (2018): 356–363.

Publication types

MeSH terms

LinkOut - more resources