Peer Review in Pharmacovigilance: Lens on Disproportionality Analysis.

Autor: Raschi, Emanuel, Salvo, Francesco, Bate, Andrew, De Ponti, Fabrizio, Poluzzi, Elisabetta, Tuccori, Marco, van Puijenbroek, Eugène, Joshi, Nitin, Khouri, Charles
Předmět:
Zdroj: Drug Safety; Jul2024, Vol. 47 Issue 7, p601-605, 5p
Abstrakt: The article discusses the process of peer review in pharmacovigilance, specifically focusing on disproportionality analysis (DA) of individual case safety reports (ICSR) systems. It highlights the challenges and limitations of the current peer review process, such as lack of standardization and potential bias. The article emphasizes the importance of complementing DA with careful case-by-case analysis and the need for clear reporting and interpretation of results. It also suggests proposals to improve the peer review process, including standardized reporting, reviewer engagement, and reviewer training. The article concludes by calling for a more effective and innovative model of peer review in pharmacovigilance. [Extracted from the article]
Databáze: Complementary Index