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Successful Comparison of US Food and Drug Administration Sentinel Analysis Tools to Traditional Approaches in Quantifying a Known Drug-Adverse Event Association

    Basic Details

    The US Food and Drug Administration's Sentinel system has developed the capability to conduct active safety surveillance of marketed medical products in a large network of electronic healthcare databases. The authors assessed the extent to which the newly developed, semiautomated Sentinel Propensity Score Matching (PSM) tool could produce the same results as a customized protocol-driven assessment. This comparison provides initial evidence that Sentinel analytic tools can produce findings similar to those produced by a highly customized protocol-driven assessment.


    Joshua Gagne PharmD, ScD, X. Han PharmD, PhD, MS. Sean Hennessy PharmD, PhD, Charles E. Leonard PharmD, MSCE, Elizabeth Chrischilles PhD, MS, Ryan M. Carnahan PharmD, MS, BCPP, Shirley V. Wang PhD, Candace Fuller PhD, Aarthi Iyer MPH, Hannah Katcoff MPH, Tiffany S. Woodworth MPH, Patrick Archdeacon MD, Tamra E. Meyer PhD, Sebastian Schneeweiss MD, ScD, Sengwee Toh ScD

    Corresponding Author

    J. J. Gagne, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. Email: