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Infrastructure for Evaluation of Statistical Alerts Arising from Vaccine Safety Data Mining Activities in Mini-Sentinel

    Basic Details
    Date Posted
    Status
    Complete
    Description

    Methods project to: 

    1. Integrate a data freeze into the Tree Extraction and Analysis process for one TreeScan method 
    2. Develop a means by which limited, de-identified, patient-level case data associated with selected alerts could be retrieved from the Data Partner sites and 
    3. Create a reporting tool for FDA and Mini-Sentinel clinicians and investigators to use in reviewing the case data
    Workgroup Leader(s)

    David Cole, BM; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA 

    Workgroup Member(s)

    Meghan Baker, MD, ScD; Grace Lee, MD, MPH; Judith C. Maro, PhD, MS; Inna Dashevsky, MS; W. Katherine Yih, PhD, MPH; Carolyn Balsbaugh, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Martin Kulldorff, PhD; Division of Pharmacoepidemiology & Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

    Estelle Russek-Cohen, PhD; David Martin, MD, MPH; Michael Nguyen, MD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD