中国临床药理学与治疗学2013，Vol.18Issue(2)：175-180,6.
肿瘤药物临床试验中成组序贯设计的统计学考虑
Statistical considerations of group sequential design in oncology clinical trials
摘要
Abstract
The group sequential design is a good choice of oncology trial design because of the smaller sample size and the probability of early stopping for efficacy/futility.To design and apply the group sequential trials scientifical ly, we illustrate how to choose the number, tim ing of interim analysis, alpha spending function and optimal trial parameters by employing Monte Carlo simulation.The simulation results show that the three-stage design of 2 : 1 : 1 time point, whose expected sample size is 420.53, is the best choice in the group sequential design. And the expect sample size is only 420.53.A mong the five a spending functions proposed by Lan and DeMets, the 1.5th power and quadratic a spending function, which have the smallest ex pect sample size of 393 cases, are better than O' Brien-Fleming and Pocock design.关键词
肿瘤临床试验/成组序贯设计/期中分析/样本量估计Key words
Oncology clinical trial/Group sequential design/Interim analysis/Sample size estimation分类
医药卫生引用本文复制引用
郭洋,蒋志伟,夏结来,王玉琨..肿瘤药物临床试验中成组序贯设计的统计学考虑[J].中国临床药理学与治疗学,2013,18(2):175-180,6.基金项目
国家自然科学基金资助项目(81072390,81001290) （81072390,81001290）
