Top 5: The analysis of adverse events done right

We’re bringing back one of our most downloaded episodes ever – a deep dive into how adverse events should be analyzed properly. This conversation with Jan Beyersmann and Kaspar Rufibach is packed with methodological insights and practical implications for statisticians working in clinical trials. Adverse event (AE) analysis has long been approached differently from efficacy analysis, often using overly simplistic methods that can bias results. In this episode, we discuss why that’s a problem – and how the SAVVY collaboration (Survival analysis for AdVerse events with Varying follow-up times) is pushing the field forward. Together with academia and multiple pharma companies, this collaboration tackled the issue of AE analysis using real randomized trial data, not just simulations. The findings show how common methods can underestimate or overestimate event probabilities and how established statistical methods can be applied more consistently to ensure fair benefit–risk assessments. If you’ve ever wondered whether your approach to safety analysis is leading to misleading conclusions, this episode is a must-listen.

You can listen to Top 5: The analysis of adverse events done right online on Radio and Podcast. Open the player on this page to stream the available audio.

Top 5: The analysis of adverse events done right is an episode from The Effective Statistician - in association with PSI by Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry.

This episode is 52:45 long.

This episode was published on Aug 25, 2025.

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