Mini-Sentinel: Taxonomy of Observational Study Designs - Phase 2

    Basic Details
    Date Posted
    Monday, April 9, 2012
    Status
    Complete
    Description

    Phase 2 of a methods project 1) to create a decision table that enables expedited matching of medical product safety questions to design and analytic approaches, and 2) to map recommended statistical methods to the epidemiologic designs delineated in Phase 1.

    Workgroup Leader(s)

    Joshua Gagne, PharmD, ScD; Sebastian Schneeweiss, MD, ScD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA

    Workgroup Member(s)

    Bruce Fireman, MA; Kaiser Permanente Northern California, Oakland, CA

    Tobias Gerhard, PhD; Department of Pharmacy Practice and Administration, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ

    Jennifer Nelson, PhD; Biostatistics Unit, Group Health Research Institute and Department of Biostatistics, University of Washington, Seattle, WA

    John Seeger, PharmD, DrPH; Jeremy Rassen, ScD; Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Boston, MA

    Azadeh Shoaibi, MS, MHS; Marsha Reichman, PhD; Office of Medical Policy, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

    Darren Toh, ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Department of Population Medicine and Harvard Medical School, Boston, MA