Show simple item record

dc.rights.licenseopenen_US
dc.contributor.authorCRISAFULLI, Salvatore
dc.contributor.authorBATE, Andrew
dc.contributor.authorBROWN, Jeffrey Stuart
dc.contributor.authorCANDORE, Gianmario
dc.contributor.authorCHANDLER, Rebecca E
dc.contributor.authorHAMMAD, Tarek A
dc.contributor.authorLANE, Samantha
dc.contributor.authorMARO, Judith Christina
dc.contributor.authorNOREN, G Niklas
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorPARIENTE, Antoine
dc.contributor.authorRUSSOM, Mulugeta
dc.contributor.authorSALAS, Maribel
dc.contributor.authorSEGEC, Andrej
dc.contributor.authorSHAKIR, Saad
dc.contributor.authorSPINI, Andrea
dc.contributor.authorTOH, Sengwee
dc.contributor.authorTUCCORI, Marco
dc.contributor.authorVAN PUIJENBROEK, Eugene
dc.contributor.authorTRIFIRO, Gianluca
dc.date.accessioned2025-05-26T11:15:03Z
dc.date.available2025-05-26T11:15:03Z
dc.date.issued2025-04-13
dc.identifier.issn0114-5916en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/206712
dc.description.abstractEnSignal management, defined as the set of activities from signal detection to recommendations for action, is conducted using different data sources and leveraging data from spontaneous reporting databases (SRDs), which represent the cornerstone of pharmacovigilance. However, the exponentially increasing generation and availability of real-world data collected in longitudinal healthcare databases (LHDs), along with the rapid evolution of artificial intelligence-based algorithms and other advanced analytical methods, offers a wide range of opportunities to complement SRDs throughout all stages of signal management, especially signal detection. Integrating information derived from SRDs and LHDs may reduce their respective limitations, thus potentially enhancing post-marketing surveillance. The aim of this position statement is to critically evaluate the complementary role of SRDs and LHDs in signal management, exploring the potential benefits and challenges in integrating information coming from these two data sources. Furthermore, we presented successful cases of the interplay between SRDs and LHDs for signal management, along with future opportunities and directions to improve such interplay.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/3.0/us/*
dc.title.enInterplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance
dc.title.alternativeDrug Safen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1007/s40264-025-01548-3en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed40223041en_US
bordeaux.journalDrug Safetyen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamAHEAD_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDUniversità degli Studi di Veronaen_US
hal.identifierhal-05084887
hal.version1
hal.date.transferred2025-05-26T11:15:08Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Drug%20Safety&rft.date=2025-04-13&rft.eissn=0114-5916&rft.issn=0114-5916&rft.au=CRISAFULLI,%20Salvatore&BATE,%20Andrew&BROWN,%20Jeffrey%20Stuart&CANDORE,%20Gianmario&CHANDLER,%20Rebecca%20E&rft.genre=article


Files in this item

Thumbnail
Thumbnail

This item appears in the following Collection(s)

Show simple item record