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 |
|
|