Journal
STATISTICA NEERLANDICA
Volume 64, Issue 2, Pages 202-226Publisher
WILEY-BLACKWELL
DOI: 10.1111/j.1467-9574.2010.00451.x
Keywords
censoring; covariate-adjusted adaptive allocation; ethics; optimality; survival data
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A randomized two-stage adaptive design is proposed and studied for allocation of patients to treatments and comparison in a phase III clinical trial with survival time as treatment responses. We consider the possibility of several covariates in the design and analysis. Several exact and limiting properties of the design and the follow-up inference are studied, both numerically and theoretically. The applicability of the proposed methodology is illustrated by using some real data.
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