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The REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Explanation and Elaboration

Authors: Michele Fusaroli,Francesco Salvo,Bernard Begaud,Thamir M. AlShammari,Andrew Bate,Vera Battini,Andreas Brueckner,Gianmario Candore,Carla Carnovale,Salvatore Crisafulli,Paola Maria Cutroneo,Charles Dolladille,Milou-Daniel Drici,Jean-Luc Faillie,Adam Goldman,Manfred Hauben,Maria Teresa Herdeiro,Olivia Mahaux,Katrin Manlik,François Montastruc,Yoshihiro Noguchi,G. Niklas Norén,Roberta Noseda,Igho J. Onakpoya,Antoine Pariente,Elisabetta Poluzzi,Myriam Salem,Daniele Sartori,Nhung T. H. Trinh,Marco Tuccori,Florence van Hunsel,Eugène van Puijenbroek,Emanuel Raschi,Charles Khouri
Publisher: Springer Science and Business Media LLC
Publish date: 2024-5-7
ISSN: 0114-5916 DOI: 10.1007/s40264-024-01423-7
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While the READUS-PV guideline offers a much-needed framework for improving the transparency and methodological rigor of disproportionality analyses (DAs) in pharmacovigilance, a critical limitation lies in its lack of attention to study prioritization and scientific necessity. Specifically, the guideline provides detailed recommendations on how to report a DA but remains silent on whether the analysis should have been conducted in the first place. This omission is problematic given the exponential rise in DA publications, many of which use overlapping datasets (such as FAERS or VigiBase) and often contribute redundant findings without offering meaningful regulatory insight or downstream validation. The paper itself acknowledges the prevalence of spin and methodological distortions in this literature, yet it does not require authors to justify the added value of their analysis in terms of novelty, unmet regulatory need, or methodological innovation. As a result, there is a risk that methodologically sound, but conceptually low-value, studies continue to be produced, contributing to research duplication, saturation of the literature, and the dilution of attention from high-priority safety signals. Integrating a formal reporting item that prompts authors to reflect on the relevance and uniqueness of their DA could strengthen the impact of the guideline, helping shift the focus from not just better reporting, but toward more responsible and strategic use of pharmacovigilance resources.

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