Might We Come Together on a Paradigm Shift to Manage ICSRs with a Decentralized Data Model?

The current practice of managing and sharing individual case safety reports (ICSRs) across the patient safety ecosystem, established in the 1960s, has become burdened with ICSR duplication and replication and can result in a fragmented understanding of product safety profiles. For this article, we have defined duplication as multiple representations of the same case within the same database and replication as various representations of the same case across numerous databases. Evolving safety regulations and increasing case volumes signal a need for a new path forward that is sustainable and enhances public health.