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Group Sequential Design for Randomized Phase III Trials under the Weibull Model
Authors:Jianrong Wu  Xiaoping Xiong
Affiliation:1. Department of Biostatistics, St. Jude Children’s Research Hospital, Memphis, Tennessee, USAjianrong.wu@stjude.org;3. Department of Biostatistics, St. Jude Children’s Research Hospital, Memphis, Tennessee, USA
Abstract:In this article, a parametric sequential test is proposed under the Weibull model. The proposed test is asymptotically normal with an independent increment structure. The sample size for a fixed sample test is derived for the purpose of group sequential trial design. In addition, a multi-stage group sequential procedure is given under the Weibull model by applying the Brownian motion property of the test statistic and sequential conditional probability ratio test methodology.
Keywords:Brownian motion  Group sequential trial  Randomized clinical trial  Sample size  Time-to-event  Weibull distribution
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