The benefit-risk tolerability measure - a new way to reach insights into benefit-risk and more


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By Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry, Alexander Schacht, Benjamin Piske, and Leaders in the pharma industry. Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio is streamed directly from their servers. Hit the Subscribe button to track updates in Player FM, or paste the feed URL into other podcast apps.
Interview with Yves Schymura

As part of his master thesis, he worked on an idea; I had sketched out a couple of years ago but never had the time to fully think through. I wanted to explore how we could utilize existing study data to inform the benefit-risk assessment of different therapies. In this episode, you will learn a new concept which also is related to minimal clinical meaningful differences and helps to assess the impact of various adverse events on the patient. Specifically, we dive into:

  • What is the benefit-risk tolerability measure?
  • How can we use the information on which patient discontinue to inform the benefit-risk assessment?
  • How does the model help us rank adverse events in order of their importance?
  • Which adverse events cannot be classified with the model?
  • How to use the model to inform relevant difference for efficacy endpoints?

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