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Postlicensure Medical Product Safety Data-Mining: Power Calculations for Bernoulli Data

    Basic Details
    Date Posted
    Status
    Complete
    Description

    This project build upon TreeScan Power Evaluation activity funded under the PRISM 2013 task order that is developing software to enable power calculations for the tree-based scan statistic. This extension activity enhanced the TreeScan software to perform power evaluation for the tree-temporal scan statistic as well as evaluate the power for the tree-temporal scan statistic when used for adolescent vaccines, considering different sample sizes, adverse event outcomes, and relative risks.

    Additional Details
    FDA Center
    CBER
    Time Period
    June 2006 - December 2014
    Population / Cohort
    Individuals 9-26 years of age
    Data Sources
    Sentinel Distributed Database (SDD)
    Workgroup Leader(s)

    Judith C. Maro, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston MA

    Workgroup Members

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

    Inna Dashevsky, MS; Meghan Baker, MD, ScD; Claudia Coronel-Moreno, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston MA

    Steven Anderson, PhD, MPP; Azadeh Shoaibi, PhD, MHS, MS; Rositsa Dimova, MS, PhD; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

    Estelle Russek-Cohen, PhD; Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

    Corresponding Author

    Judith C. Maro, Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA. Email: jmaro@mit.edu