Framework for Assessment of Positive Results from Signal Refinement

    Basic Details
    Wednesday, January 1, 2014

    Medical product post-market safety surveillance can be conceptualized as a three stage process involving signal generation, signal refinement, and signal evaluation. This article describes a framework developed by the Mini-Sentinel pilot study for signal refinement, which involves the assessment of predefined exposure-outcome pairs to determine whether there is an association


    David L. McClure PhD; Marsha A. Raebel PharmD; W. Katherine Yih PhD, MPH; Azadeh Shoaibi PhD, MHS, MS; Jerald E. Mullersman MD, PhD, MPH; Colin Anderson-Smits MPH; Jason M. Glanz PhD

    Corresponding Author

    D. McClure, Epidemiology Research Center/ML2, Marshfield Clinic Research Foundation, 1000 North Oak Avenue, Marshfield, WI 54449, USA. E-mail: