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Safety Signal Identification in the Sentinel System: Consistent Findings for Medical Products Over Various Study Designs

    Basic Details
    Date
    Type
    Presentation
    Description

    This poster demonstrates the concurrent application of two distinct study designs leveraging tree-based scan statistics (TBSS) for the identification of safety signals in the U.S. FDA’s Sentinel System. It was presented at the 2025 Conference of the Society for Epidemiologic Research (SPER).
     

    Presenter(s)

    Ashley I. Michnick

    Author(s)

    Ashley I. Michnick, Leah B. Herity, Geetha S. Iyer, Suraj Rajasimhan, Jummai Apata, Jillian Burk, Derek Campbell, José J. Hernández-Muñoz, Michelle Hines, Nathan Kim, Joy Kolonoski, Nora McElroy, Sampada Nandyala, Amelia Thyen, Megan Wiley, Judith C. Maro, Monica A. Muñoz