Pilot Test of Sequential PSM Capabilities, Using ACEI/Beta Blockers and Angioedema

    Basic Details
    Date Posted
    Thursday, June 15, 2017
    Status
    Complete
    Medical Product
    angiotensin-converting enzyme (ACE) inhibitor
    beta blocker
    Health Outcome(s)
    angioedema
    Description

    Prospective sequential surveillance of medical products is a core component of FDA’s Active Risk Identification and Analysis System (ARIA). However, FDA has had limited experience using these sequential tools and their capabilities have evolved quickly over time. To prepare for implementing sequential analyses, Sentinel will conduct a “live” pilot test of the new sequential surveillance modes associated with sequential propensity score matched (PSM) analyses using a “known positive” association that has already been studied in a protocol-based assessment. 

    Workgroup Leader(s)

    Judith C. Maro, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Workgroup Member(s)

    Austin C. Cosgrove; Laura Hou, MS; Catherine Rogers Murray, MPH; Darren Toh, ScD; Zilu Zhang, MS; Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA

    Efe Eworuke, PhD; Margie Goulding, PhD; Michael D. Nguyen, MD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA, Silver Spring, MD

    Bruce Fireman, MA; Kaiser Permanente Northern California, Oakland, CA

    Rima Izem, PhD; Joo-Yeon Lee, PhD; Office of Biostatistics, Center for Drug Evaluation and Research, FDA, Silver Spring, MD