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

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dc.contributor.authorChen, Cong
dc.contributor.authorSun, Linda
dc.contributor.authorZhang, Xuekui
dc.date.accessioned2024-01-23T23:12:08Z
dc.date.available2024-01-23T23:12:08Z
dc.date.copyright2023en_US
dc.date.issued2023
dc.description.abstractThis 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.en_US
dc.description.reviewstatusRevieweden_US
dc.description.scholarlevelFacultyen_US
dc.description.sponsorshipXZ is a Canada Research Chairs scholar (grant number: CRC-2021-00232) and a Michael Smith Health Research BC scholar (grant number: SCH-2022-2553).en_US
dc.identifier.citationChen, 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.2023.101229en_US
dc.identifier.urihttps://doi.org/10.1016/j.conctc.2023.101229
dc.identifier.urihttp://hdl.handle.net/1828/15847
dc.language.isoenen_US
dc.publisherContemporary Clinical Trials Communicationsen_US
dc.subject.departmentDepartment of Mathematics and Statistics
dc.titleA promising biomarker adaptive Phase 2/3 design – Explained and expandeden_US
dc.typeArticleen_US

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