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