Mini-Sentinel: Evaluating Strategies for Data Sharing and Analyses in Distributed Data Settings

    Basic Details
    Date Posted
    Friday, January 11, 2013
    Status
    Complete
    Description

    Report enumerating, describing, and evaluating major available analytical and data handling strategies that have been used or proposed in distributed data systems or similar settings. This report describes the key issues that are important to consider when evaluating such strategies for data handling and analysis, assesses the strengths and limitations of each approach with respect to identified issues, and provides recommendations of potential strategies that are most appropriate for the Mini-Sentinel environment.

    Workgroup Leader(s)

    Jeremy A. Rassen, ScD; Division of Pharmacoepidemiology, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

    John H. Holmes, PhD; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA

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

    Workgroup Member(s)

    Tarek A. Hammad, MD, PhD, MSc, MS; Division of Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD 

    Kevin Haynes, PharmD, MSCE; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA

    Karin Johnson, PhD; Group Health Research Initiative, Seattle, WA

    Mary K. Kowal; John Moran; Jessica Myers, PhD; Sebastian Schneeweiss, MD, ScD; Division of Pharmacoepidemiology, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

    Marsha A. Raebel, PharmD; Kaiser Permanente Colorado Institute for Health Research, Denver, CO.

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