A Problematic Biomarker Trial Design.

Freidlin, Boris; Korn, Edward L · J Natl Cancer Inst · 2022

review · Level V

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Abstract

Efficient biomarker-driven randomized clinical trials are a key tool for implementing precision oncology. A commonly used biomarker phase III design is focused on testing the treatment effect in biomarker-positive and overall study populations. This approach may result in recommending new treatments to biomarker-negative patients when these treatments have no benefit for these patients.

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