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Studying The Properties Of Seamless Phase Ii/Phase Iii Clinical Trials Under Covariate Adaptive Randomization, Garrett Miller

Dissertations & Theses (Open Access)

Covariate adaptive randomization is an allocation procedure used in clinical trials that seeks to balance treatment groups. While this method has been shown to reduce bias due to imbalanced treatment groups, the effects of covariate adaptive randomization have not been studied under seamless Phase II/Phase III clinical trials that incorporate short-term endpoint information and treatment selection. Therefore, this analysis sought to determine whether these adaptive randomization methods can be applied to seamless Phase II/Phase III trials while preserving Type I error. In addition, this analysis sought to create R-packages that employ seamless Phase II/Phase III techniques to provide analysis tools …