Patient-reported outcomes and the FDA Patient-Focused Drug Development Guidance
The Effective Statistician - in association with PSI
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Analyzing Data in a Puros Setting?
In the draft guidance, there are a couple of analysis that maybe are especially suitable for apuros. The first is a landmark analysis which looks at data up to a fixed time point. So i'm used to using landmark analisis more in a kind of survival onchology setting,. whereas they're kind of using same language to say that they want to look up to a certain time point. But it's always good to have an example.
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