Supporting Pharmacovigilance Signal Validation and Prioritization with Analyses of Routinely Collected Health Data: Lessons Learned from an EHDEN Network Study.
Oskar GauffinJudith S BrandSara Hedfors VidlinDaniele SartoriSuvi AsikainenMartí CatalàEtir ChalabiDaniel DedmanAna DanilovicTalita Duarte-SallesMaria Teresa García MoralesSaara HiltunenAnnika M JödickeMilan LazarevicMiguel A MayerJelena MiladinovicJoseph MitchellAndrea PistilloJuan Manuel Ramírez-AnguitaCarlen ReyesAnnette RudolphLovisa SandbergRuth SavageMartijn SchuemieDimitrije SpasicNhung T H TrinhNevena VeljkovicAnkica VujovicMarcel de WildeAlem ZekariasPeter RijnbeekPatrick RyanDaniel Prieto-AlhambraG Niklas NorénPublished in: Drug safety (2023)
Analyses of routine health data from a distributed network to support signal validation and prioritization are feasible in the given time limits and can inform decision making. The cost-benefit of integrating these analyses at this stage of signal management requires further research.