Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
6150949 | Contemporary Clinical Trials | 2015 | 8 Pages |
Abstract
This design approach differs from typical enrichment design or stratified all-comer design in that the former enrolls only biomarker-positive patients and the latter enrolls a regular all-comer population. It also differs from adaptive enrichment by maintaining the trial design and analysis priority on biomarker-positive subpopulation. Therefore the proposed approach not only warrants a high probability of trial success on biomarker-positive subpopulation, but also efficiently assesses the overall treatment effect in the presence of an uncertain treatment benefit among biomarker-negative patients.
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Authors
Bo Yang, Yijie Zhou, Lanju Zhang, Lu Cui,