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. 2022 Nov 14;29(12):2191-2200.
doi: 10.1093/jamia/ocac153.

The US Food and Drug Administration Sentinel System: a national resource for a learning health system

Jeffrey S Brown  1 , Aaron B Mendelsohn  1 , Young Hee Nam  1 , Judith C Maro  1 , Noelle M Cocoros  1 , Carla Rodriguez-Watson  2 , Catherine M Lockhart  3 , Richard Platt  1 , Robert Ball  4 , Gerald J Dal Pan  4 , Sengwee Toh  1
Affiliations

The US Food and Drug Administration Sentinel System: a national resource for a learning health system

Jeffrey S Brown et al. J Am Med Inform Assoc. .

Abstract

The US Food and Drug Administration (FDA) created the Sentinel System in response to a requirement in the FDA Amendments Act of 2007 that the agency establish a system for monitoring risks associated with drug and biologic products using data from disparate sources. The Sentinel System has completed hundreds of analyses, including many that have directly informed regulatory decisions. The Sentinel System also was designed to support a national infrastructure for a learning health system. Sentinel governance and guiding principles were designed to facilitate Sentinel's role as a national resource. The Sentinel System infrastructure now supports multiple non-FDA projects for stakeholders ranging from regulated industry to other federal agencies, international regulators, and academics. The Sentinel System is a working example of a learning health system that is expanding with the potential to create a global learning health system that can support medical product safety assessments and other research.

Keywords: Sentinel; learning health system; real-world data; real-world evidence.

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Figures

Figure 1.
Figure 1.
Architecture of the US Food and Drug Administration Sentinel System. FDA: Food and Drug Administration; FISMA: Federal Information Security Management Act; SOC: Sentinel Operations Center.
Figure 2.
Figure 2.
Uses of Sentinel’s common informatics infrastructure to support a learning health system.
See this image and copyright information in PMC

References

    1. Food and Drug Administration Amendments Act of 2007. Pub. L. No. 110-85. 21 U.S.C. Stat 823. https://www.govinfo.gov/content/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf. Accessed February, 2022.
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    1. Ball R, Robb M, Anderson SA, et al.The FDA’s Sentinel Initiative—a comprehensive approach to medical product surveillance. Clin Pharmacol Ther 2016; 99 (3): 265–8. - PubMed
    1. Platt R, Brown JS, Robb M, et al.The FDA Sentinel Initiative—an evolving national resource. N Engl J Med 2018; 379 (22): 2091–3. - PubMed

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