Using and improving distributed data networks to generate actionable evidence: the case of real-world outcomes in the Food and Drug Administration's Sentinel system. (11th April 2020)

• Record Type: Journal Article
• Authors: Brown, Jeffrey S; Maro, Judith C; Nguyen, Michael; Ball, Robert
• Is Part Of: Journal of the American Medical Informatics Association. Volume 27:Number 5(2020)
• Page Start: 793
• Page End: 797
• Publication Date: 2020-04-11
• Subjects: health outcomes -- drug safety surveillance -- distributed networks, computable phenotypes, electronic health data; Medical informatics -- Periodicals; Information Services -- Periodicals; Medical Informatics -- Periodicals; Médecine -- Informatique -- Périodiques; Informatica; Geneeskunde; Informatique médicale; Computer network resources; Electronic journals; 610.285
• DOI: 10.1093/jamia/ocaa028
• Languages: English
• ISSNs: 1067-5027

Abstract

Abstract: The US Food and Drug Administration (FDA) Sentinel System uses a distributed data network, a common data model, curated real-world data, and distributed analytic tools to generate evidence for FDA decision-making. Sentinel system needs include analytic flexibility, transparency, and reproducibility while protecting patient privacy. Based on over a decade of experience, a critical system limitation is the inability to identify enough medical conditions of interest in observational data to a satisfactory level of accuracy. Improving the system's ability to use computable phenotypes will require an "all of the above" approach that improves use of electronic health data while incorporating the growing array of complementary electronic health record data sources. FDA recently funded a Sentinel System Innovation Center and a Community Building and Outreach Center that will provide a platform for collaboration across disciplines to promote better use of real-world data for decision-making.