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

Lucinda Smith, Michael Glaser, Dieter Kempf (), Xaymara Roman, Charlotte Artlich, Mayur A. Patel and Andrew Bate
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Lucinda Smith: Roche Products Limited
Michael Glaser: GlaxoSmithKline
Dieter Kempf: Genentech, A Member of the Roche Group
Xaymara Roman: Astellas Pharma Inc
Charlotte Artlich: Bayer AG
Mayur A. Patel: AstraZeneca
Andrew Bate: GSK

Drug Safety, 2025, vol. 48, issue 8, No 1, 843-853

Abstract: Abstract 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. While there is no question that ICSRs are a crucial component of safety surveillance, stakeholders must evaluate their management to ensure they are fit for purpose in a modern ecosystem. This article aims to embark on that path by proposing a conceptual decentralized ICSR management model to facilitate multi-stakeholder collaboration around new working models to mitigate duplication and replication, allow ecosystem stakeholders to access the latest source of truth on demand, facilitate more meaningful safety analysis and interpretation, and ultimately enable a real-time learning healthcare system to improve patient safety and health outcomes. It describes the feasibility analysis results and subsequently conducted proof of concept (PoC) based on a decentralized system architecture supporting such a decentralized model. It outlines considerations, challenges, and opportunities compared with the current state related to case management and signal management processes.

Date: 2025
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DOI: 10.1007/s40264-025-01539-4

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