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Mini-Sentinel: Framework for Assessment of Signal Refinement Positive Results

    Basic Details
    Date Posted

    This report describes a framework for assessment of signal refinement positive results. “Positive results” are defined to be when an association is detected between a medical product and an adverse outcome that exceeds a pre-specified threshold in the direction of increased risk. The principal goal was to determine if the excess risk can be explained by something other than a cause and effect relationship, such as information or selection bias, confounding, or any errors associated with the signal refinement results. This report addressed assessing signal refinement, which is the second of a three stage process (signal generation, signal refinement, signal evaluation) in medical product post-market safety surveillance.

    Workgroup Leader(s)

    David L McClure, PhD; Marshfield Epidemiology Research Center, Marshfield Clinic, Marshfield, WI

    Workgroup Member(s)

    Colin Anderson-Smits, MPH; Center for Devices and Radiological Health, FDA, Silver Spring, MD

    Aloka Chakravarty, PhD; Clara Kim, PhD; Rita Ouellet-Hellstrom PhD; Center for Disease Evaluation and Research, FDA, Silver Spring, MD

    Jason M. Glanz, PhD; Institute for Health Research, Kaiser Permanente Colorado, Denver CO

    Jerry Mullersman, MD, PhD, MPH; Center for Biologics Evaluation and Research, FDA, Silver Spring, MD

    Marsha A. Raebel, PharmD, BCPS, FCCP; Institute for Health Research, Kaiser Permanente Colorado, Denver CO and University of Colorado Skaggs School of Pharmacy and Pharmaceutical Science, Aurora, CO

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

    W. Katherine Yih, PhD, MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston MA