The reporting of disproportionality analysis in pharmacovigilance: spotlight on the READUS-PV guideline.

ABSTRACT: Disproportionality analyses are the most-commonly used study design used in the post-marketing phase to detect suspected adverse drug reactions in individual case safety reports. Recent years have witnessed an exponential increase in published articles on disproportionality analyses, thanks to publicly accessible databases. Unfortunately, this trend was accompanied by concerns on lack of transparency and misinterpretation of results, both generating unjustified alarm and diluting true signals into overwhelming noise. The READUS-PV guideline for reporting disproportionality analysis was developed to tackle this emerging issue. In this perspective article, we describe the rationale behind the development of the READUS-PV guideline, the first collaborative initiative to harmonize the reportin

SUBMITTER: Fusaroli M 

PROVIDER: S-EPMC11632231 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature