The Reporting of a Disproportionality Analysis for Drug Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance (READUS-PV): Development and Statement.
Michele FusaroliFrancesco SalvoBernard BegaudThamir M AlShammariAndrew BateVera BattiniAndreas BruecknerGianmario CandoreCarla CarnovaleSalvatore CrisafulliPaola Maria CutroneoCharles DolladilleMilou-Daniel DriciJean-Luc FaillieAdam GoldmanManfred HaubenMaria Teresa HerdeiroOlivia MahauxKatrin ManlikFrançois MontastrucYoshihiro NoguchiG Niklas NorénRoberta NosedaIgho J OnakpoyaAntoine ParienteElisabetta PoluzziMyriam SalemDaniele SartoriNhung T H TrinhMarco TuccoriFlorence van HunselEugène van PuijenbroekEmanuel RaschiCharles KhouriPublished in: Drug safety (2024)
The READUS-PV guidelines will support authors, editors, peer-reviewers, and users of disproportionality analyses using individual case safety report databases. Adopting these guidelines will lead to more transparent, comprehensive, and accurate reporting and interpretation of disproportionality analyses, facilitating the integration with other sources of evidence.