适应性设计
临床终点
灵活性(工程)
选择(遗传算法)
人口
计算机科学
阶段(地层学)
相(物质)
肿瘤科
内科学
临床试验
医学
统计
数学
机器学习
生物
环境卫生
古生物学
有机化学
化学
作者
Martin Jenkins,Andrew Stone,Christopher Jennison
摘要
Abstract Although the statistical methods enabling efficient adaptive seamless designs are increasingly well established, it is important to continue to use the endpoints and specifications that best suit the therapy area and stage of development concerned when conducting such a trial. Approaches exist that allow adaptive designs to continue seamlessly either in a subpopulation of patients or in the whole population on the basis of data obtained from the first stage of a phase II/III design: our proposed design adds extra flexibility by also allowing the trial to continue in all patients but with both the subgroup and the full population as co‐primary populations. Further, methodology is presented which controls the Type‐I error rate at less than 2.5% when the phase II and III endpoints are different but correlated time‐to‐event endpoints. The operating characteristics of the design are described along with a discussion of the practical aspects in an oncology setting. Copyright © 2010 John Wiley & Sons, Ltd.
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