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Drug Safety MattersAuthor: Uppsala Monitoring Centre
Drug Safety Matters brings you the best stories from the world of pharmacovigilance. Through in-depth interviews with our guests, we cover new research and trends, and explore the most pressing issues in medicines safety today. Produced by Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring. The views and opinions expressed in the podcast are those of the hosts and guests respectively and, unless otherwise stated, do not represent the position of any institution to which they are affiliated. Language: en Genres: Health & Fitness, Life Sciences, Medicine, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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#45 How to perform better disproportionality analyses – Michele Fusaroli & Eugene van Puijenbroek
Thursday, 26 March, 2026
Send a text message to the show!For all its ease and speed, disproportionality analysis can be distorted by many biases, making it easy to misuse and misinterpret. Michele Fusaroli from Uppsala Monitoring Centre and Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb explain why we shouldn’t abuse this powerful but fragile tool.Tune in to find out:Why we should never treat disproportionality signals as verdictsHow poorly performed analyses affect scientists, regulators and patientsHow to avoid the most common sources of bias Want to know more?Michele and Eugene’s paper in Drug Safety is a concrete guide to charting and sidestepping the pitfalls of disproportionality analysis.In another Drug Safety paper, Michele and colleagues show how directed acyclic graphs (DAGs) can help map and address biases in disproportionality analysis.Michele also reviewed the method’s limitations in Uppsala Reports, where he argues that ‘pharmacovigilance must move past crude disproportionality’.Last year, Retraction Watch covered the spike in pharmacovigilance studies in the literature and why some journals decided to ban drug safety database papers.Previously on Drug Safety Matters, Michele and Daniele Sartori discussed the READUS-PV guidelines for reporting disproportionality analyses.In 2016, the IMI PROTECT project published recommendations to improve signal detection practices, especially for quantitative methods like disproportionality analysis.UMC’s guidebook on signal detection in small datasets offers step-by-step advice for qualitative methods and manual case review.Got a story to share?We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!About UMCUppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.
