| アブストラクト | In recent years, different national and international regulatory authorities, notably the FDA, have made their adverse event repositories publicly available, offering user-friendly dashboards. This has led to a large increase in low-quality, poorly reported research using adverse event reporting databases (e.g., FDA's Adverse Event Reporting System [FAERS]). Such publications producing thousands of statistical associations erroneously presented as "safety signals" can create unscientifically grounded alarm with considerable impact on healthcare provider practices and patient behaviors. |
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| 投稿者 | Khouri, Charles; Hlavaty, Alex; Fusaroli, Michele; Joshi, Nitin; Salvo, Francesco; Bate, Andrew; Pariente, Antoine; Raschi, Emanuel |
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| 組織名 | Univ. Grenoble Alpes, Pharmacovigilance Unit, Grenoble Alpes University Hospital,;Grenoble, France.;Univ. Grenoble Alpes, Inserm U1300, HP2, Grenoble, France.;Uppsala Monitoring Centre, Uppsala, Sweden.;Springer Nature, Auckland, New Zealand.;INSERM, BPH, Team AHeaD U1219, Universite de Bordeaux, Bordeaux, France.;INSERM U1219, CHU de Bordeaux, Service de Pharmacologie Medicale, Bordeaux,;France.;Global Safety, GSK, Brentford, UK.;Department of Non-Communicable Epidemiology, London School of Hygiene and;Tropical Medicine, London, UK.;Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of;Bologna, Bologna, Italy. |
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