Re-Using Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals via Modular Analytic Programs

    Basic Details
    Date
    Wednesday, August 7, 2013
    Type
    Publication
    Description

    This article summarizes deliberations of a Mini-Sentinel expert committee on re-use of Mini-Sentinel data to conduct subsequent analyses on the same exposure-outcome pair following rapid assessment of potential safety signals using customizable modular programs.  When appropriate, general non-binding recommendations are provided.

    Author(s)

    Sengwee Toh ScD; Jerry Avorn MD; Ralph B. D'Agostino Sr. PhD; Jerry H. Gurwitz MD; Bruce M. Psaty MD, PhD; Kenneth J. Rothman DrPH; Kenneth G. Saag MD, MSc; Miriam C.J.M. Sturkenboom PhD; Jan P. Vandenbroucke MD, PhD; Almut G. Winterstein RPh, PhD; Brian L. Strom MD, MPH

    Corresponding Author

    S. Toh, Department of Population Medicine, Harvard Pilgrim Healthcare Institute and Harvard Medical School, 401 Park Drive, Suite 401 East, Boston, MA 02215, USA. Email: darren_toh@harvardpilgrim.org