An IPCW Adjusted Win Statistics Approach in Clinical Trials Incorporating Equivalence Margins to Define Ties

临床试验中采用IPCW调整后的胜率统计方法,结合等效性界值来定义平局

阅读:1

Abstract

In clinical trials, multiple outcomes of different priorities commonly occur as the patient's response may not be adequately characterized by a single outcome. Win statistics are appealing summary measures for between-group difference at more than one endpoint. When defining the result of pairwise comparisons of a time-to-event endpoint, it is desirable to allow ties to account for incomplete follow-up and not clinically meaningful difference in endpoints of interest. In this article, we propose a class of win statistics for time-to-event endpoints with a user-specified equivalence margin. These win statistics are identifiable in the presence of right censoring and do not depend on the censoring distribution. We then develop estimation and inference procedures for the proposed win statistics based on inverse-probability-of-censoring weighting adjustment to handle right censoring. We conduct extensive simulations to investigate the operational characteristics of the proposed procedure in the finite sample setting. A real oncology trial is used to illustrate the proposed approach.

特别声明

1、本页面内容包含部分的内容是基于公开信息的合理引用;引用内容仅为补充信息,不代表本站立场。

2、若认为本页面引用内容涉及侵权,请及时与本站联系,我们将第一时间处理。

3、其他媒体/个人如需使用本页面原创内容,需注明“来源:[生知库]”并获得授权;使用引用内容的,需自行联系原作者获得许可。

4、投稿及合作请联系:info@biocloudy.com。