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Development and Application of Two Semi-Automated Tools for Targeted Medical Product Surveillance in a Distributed Data Network

    Basic Details

    An important component of the Food and Drug Administration’s Sentinel Initiative is the active post-market risk identification and analysis (ARIA) system, which utilizes semi-automated, parameterized computer programs to implement propensity-score adjusted and self-controlled risk interval designs to conduct targeted surveillance of medical products in the Sentinel Distributed Database. In this manuscript, the authors review literature relevant to the development of these programs and describe their application within the Sentinel Initiative.


    John G. Connolly SM, Shirley V. Wang PhD, ScM, Candace C. Fuller PhD, Sengwee Toh ScD, Catherine A. Panozzo PhD, Noelle Cocoros DSc, Meijia Zhou MHS, Joshua J. Gagne PharmD, ScD, Judith C. Maro PhD, MS

    Corresponding Author

    J. G. Connolly, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Email: