Chen Jie:An Improved Approach to Simultaneous Tests of Superiority and Noninferiority on Multiple Endpoints in Clinical Trials

时间:2016-12-14浏览:189设置

报告时间:122310:30

报告地点:统计楼105

报告题目:An Improved Approach to Simultaneous Tests of Superiority and Noninferiority on Multiple Endpoints in Clinical Trials

报告人:Chen Jie教授 诺华制药

摘要:

 Simultaneous tests of superiority-noninferiority on multiple primary endpoints are often considered in clinical trials whose positive conclusion relies on the demonstration of superiority on at least one endpoint and noninferiority on the rest of endpoints when comparing a new treatment with a control. Existing methods have been shown conservativeness in the sense of study power, especially when noninferiority margins are close to zero. In this research, we proposed a new method by employing the improved Bonferroni inequalities for the control of Type I error rate that is based upon the union-intersection and intersection-union tests with least favorable superiority-noninferiority configurations. While the proposed method is proved to control the Type I error rate at pre-specified level, it has some advantages over existing methods with respect to the gain of study power in certain scenarios which is shown in simulation studies. A real example is given to illustrate the application of the new method.


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