A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs.
Ameet SarpatwariMayookha Mitra-MajumdarKatsiaryna BykovJerry AvornSteven WoloshinGita A ToyserkaniCynthia LaCivitaClaudia ManzoEsther H ZhouEllen PinnowGerald J Dal PanJoshua J GagneKrista F HuybrechtsWilliam B FeldmanKristyn ChinAaron S KesselheimPublished in: Drug safety (2021)
These research activities will evaluate the performance of REMS programs, provide information on the benefits and burdens to patients and healthcare providers, and generate recommendations for actionable steps to improve REMS programs overall.