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The Effective Statistician – in association with PSI

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

40 min • 11 november 2020
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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