A promising biomarker adaptive Phase 2/3 design – Explained and expanded

This short communication concerns a biomarker adaptive Phase 2/3 design for new oncology drugs with an uncertain biomarker effect. Depending on the outcome of an interim analysis for adaptive decision, a Phase 2 study that starts in a biomarker enriched subpopulation may continue to the end without...

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Bibliographic Details
Main Authors: Cong Chen, Linda Sun, Xuekui Zhang
Format: Article
Language:English
Published: Elsevier 2023-12-01
Series:Contemporary Clinical Trials Communications
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865423001758