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...
Main Authors: | , , |
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Format: | Article |
Language: | English |
Published: |
Elsevier
2023-12-01
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Series: | Contemporary Clinical Trials Communications |
Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865423001758 |