Mini-Sentinel: Re-Use of Mini-Sentinel Data Following Rapid Assessments of Potential Safety Signals Using Customizable Modular Programs

    Basic Details
    Date Posted
    Tuesday, December 4, 2012
    Status
    Complete
    Description

    Report summarizing the deliberations of the Mini-Sentinel Data Re-Use Committee with regard to re-using data for subsequent assessments of potential safety signals following rapid assessments of the same signals using customizable modular programs.

    Information
    Data Source(s)
    Mini-Sentinel Distributed Database (MSDD)
    Workgroup Leader(s)

    Brian L. Strom, MD, MPH; Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA

    Workgroup Member(s)

    Ralph B. D’Agostino, Sr., PhD; Department of Mathematics and Statistics, Boston University, Boston, MA

    Jerry Avorn, MD; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA

    Jerry H. Gurwitz, MD; Meyers Primary Care Institute and Division of Geriatric Medicine, University of Massachusetts Medical School, Worcester, MA

    Bruce M. Psaty, MD, PhD; Group Health Research Institute and Cardiovascular Health Research Unit, Departments of Medicine, Epidemiology, and Health Services, University of Washington, Seattle, WA

    Kenneth J. Rothman, DrPH; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital and Harvard Medical School, and Department of Epidemiology, Boston University School of Public Health, Boston, MA and RTI Health Solutions, RTI International, Research Triangle Park, NC

    Kenneth G. Saag, MD, MSc; Division of Clinical Immunology and Rheumatology, The University of Alabama at Birmingham, Birmingham, AL

    Miriam Sturkenboom, PhD; Departments of Epidemiology and Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands

    Jan P. Vandenbroucke, MD, PhD; Department of Clinical Epidemiology, Leiden University Medical School, Leiden, The Netherlands

    Almut G. Winterstein, RPh, PhD; Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, and Department of Epidemiology, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL