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

Project Title Pilot Test of Sequential PSM Capabilities, Using ACEI/Beta Blockers and Angioedema
Date Posted
Thursday, June 15, 2017
Status
In progress
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 Members

Austin C. Cosgrove BS; Laura Hou MS; Catherine Rogers 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

Medical Product
angiotensin-converting enzyme (ACE) inhibitor
beta blocker
Health Outcome
angioedema
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