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

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chen_cong_ContempClinTrialsCommun_2023.pdf (746.03 KB)

Date

2023

Authors

Chen, Cong
Sun, Linda
Zhang, Xuekui

Journal Title

Journal ISSN

Volume Title

Publisher

Contemporary Clinical Trials Communications

Abstract

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 expansion to Phase 3, expand to Phase 3 in the same population or expand to Phase 3 in a broader population. Each path can enjoy full alpha for hypothesis testing without inflating the overall Type I error.

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Citation

Chen, C., Sun, L., & Zhang, X. (2023). A promising biomarker adaptive Phase 2/3 design – Explained and expanded. Contemporary Clinical Trials Communications, 36, 101229. https://doi.org/10.1016/j.conctc.2023.101229

URI

https://doi.org/10.1016/j.conctc.2023.101229
 http://hdl.handle.net/1828/15847

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