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When there is more than one potentially predictive biomarker for a new drug, the drug is often evaluated in different subpopulations defined by different biomarkers. We aim to (i) estimate the risk of false-positive findings with this approach and (ii) evaluate the cross-validated adaptive signature design (CVASD) as a potential alternative.

Impact of Biomarker-based Design Strategies on the Risk of False-Positive Findings in Targeted Therapy Evaluation