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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Detalles Bibliográficos
Autores principales: Chen, Cong, Sun, Linda, Zhang, Xuekui
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10684793/
https://www.ncbi.nlm.nih.gov/pubmed/38034840
http://dx.doi.org/10.1016/j.conctc.2023.101229
Descripción
Sumario: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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