Adaptive expansion of biomarker populations in phase 3 clinical trials

It is well documented in this genomic era that an investigational new drug may have greater treatment effect in a biomarker positive population than in the biomarker negative population. However, limited by preclinical data and early phase clinical data, a lot of Phase 3 confirmatory trials are init...

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Bibliographische Detailangaben

Veröffentlicht in:	Contemporary clinical trials 2018-08, Vol.71, p.181-185
Hauptverfasser:	Chen, Cong, Li, Xiaoyun (Nicole), Li, Wen, Beckman, Robert A.
Format:	Artikel
Sprache:	eng
Schlagworte:	Adaptive design Bonferroni correction Intermediate endpoint Predictive biomarker Two-stage design
Online-Zugang:	Volltext
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