|Project Title||Pilot Test of Sequential PSM Capabilities, Using ACEI/Beta Blockers and Angioedema|
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.
Wednesday, August 26, 2020
Final Results and Reports