Characteristics of Study Design and Elements that may Contribute to the Success of Electronic Safety Monitoring Systems

    Basic Details
    Sunday, September 28, 2014
    Medical Product
    angiotensin-converting enzyme (ACE) inhibitor
    Health Outcome(s)

    This article describes elements that contribute to the success of electronic safety monitoring systems. Specifically, the authors examine the characteristics of a single drug-outcome pair, for which two large collaborative groups have come to results that have many points in common. Using examples, their goal is to suggest features of a disease problem and data systems that may lead to repeatable findings.

    The article focuses in particular on the association between angiotensin-converting enzyme (ACE) inhibitors and angioedema. The two analytic groups considered are the FDA’s Mini-Sentinel distributed data network and the Observational Medical Outcomes Partnership (OMOP).


    Carlos Bell MPH; Aloka Chakravarty PhD; Susan Gruber PhD, MPH, MS; Susan R. Heckbert; Mark Levenson; David Martin MD; Jennifer C. Nelson PhD; Simone Pinheiro ScD; Bruce M. Psaty MD, PhD; Christian G. Reich MD, PhD; Sebastian Schneeweiss MD, ScD; Azadeh Shoaibi PhD, MS, MHS; Sengwee Toh ScD; Alexander M. Walker MD, PhD

    Corresponding Author

    A. M. Walker, World Health Information Science Consultants, Riverside Center, Suite 2-400, 275 Grove Street, Newton, MA 02466, USA. Email: