具有适应性治疗选择的灵活序贯组设计中的检验与估计

Testing and estimation in flexible group sequential designs with adaptive treatment selection.

作者信息

Posch Martin, Koenig Franz, Branson Michael, Brannath Werner, Dunger-Baldauf Cornelia, Bauer Peter

机构信息

Section of Medical Statistics, Core Unit for Medical Statistics and Informatics, Medical University of Vienna, Spitalgasse 23, A-1090 Wien, Austria.

出版信息

Stat Med. 2005 Dec 30;24(24):3697-714. doi: 10.1002/sim.2389.

DOI:10.1002/sim.2389

PMID:16320264

Abstract

Integrating selection and confirmation phases into a single trial can expedite the development of new treatments and allows to use all accumulated data in the decision process. In this paper we review adaptive treatment selection based on combination tests and propose overall adjusted p-values and simultaneous confidence intervals. Also point estimation in adaptive trials is considered. The methodology is illustrated in a detailed example based on an actual planned study.

摘要

将选择阶段和确认阶段整合到一个单一试验中，可以加快新治疗方法的开发，并允许在决策过程中使用所有积累的数据。在本文中，我们回顾了基于联合检验的适应性治疗选择，并提出了总体调整后的p值和同时置信区间。此外，还考虑了适应性试验中的点估计。通过一个基于实际计划研究的详细例子来说明该方法。