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Adaptive designs for subpopulation analysis optimizing utility functions

Adaptive designs for subpopulation analysis optimizing utility functions

If the response to treatment depends on genetic biomarkers, it is important to identify predictive biomarkers that define (sub‐)populations where the treatment has a positive benefit risk balance. One approach to determine relevant subpopulations are subgroup analyses where the treatment effect is estimated in biomarker positive and biomarker negative groups. …