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