A guideline for the reporting of pharmacovigilance disproportionality studies: co-leading the elaboration of READUS-PV
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In 2024, the AHeaD team made a significant contribution to pharmacovigilance research by co-developing the READUS-PV guide. This international initiative, co-directed by Professor Francesco Salvo, was launched in response to the need for standardised reporting in disproportionality analyses, which are essential for detecting drug safety signals
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In addition to a checklist to control the correct structuring of articles, READUS-PV (REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance) focuses on transparent, reproducible and robust reporting practices, promoting better integration of pharmacovigilance data with other sources of evidence.
This project was developed by experts from different countries, with participants from France, Italy, the United Kingdom, the United States, Japan, India, Brazil and Canada.
This global collaboration reflects the universal importance of improving reporting standards for disproportionality analyses in pharmacovigilance.
The participation of BPH’s AHeaD team in the READUS-PV project reflects its commitment to advancing research in pharmacovigilance signal detection.