Defining information fractions in group sequential clinical trials with multiple endpoints

被引：3

作者：

Xu, Tu ^{[1
]}

Qin, Qin ^{[1
]}

Wang, Xin ^{[1
]}

机构：

[1] AbbVie Inc, N Chicago, IL 60064 USA

来源：

CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS | 2018年 / 10卷

关键词：

Information fraction; Group sequential design; Family-wise error rate; Clinical trial;

D O I：

10.1016/j.conctc.2018.03.005

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

The group sequential design has been well understood and widely applied in designs of late phase clinical trial to enable potentially early stopping for efficacy or futility. The information fraction (IF) is one of the key elements to determine the decision boundary at the interim analyses. The family-wise error rate (FWER) control is highly critical for clinical trials with multiple endpoints to be tested. In this article, we illustrate the importance of properly defining the information fraction for each individual endpoint regarding the FWER control through the numerical evaluation and a case study.

引用

页码：77 / 79

页数：3

共 11 条

[1] INTERIM ANALYSIS - THE ALPHA-SPENDING FUNCTION-APPROACH [J].