GROUP SEQUENTIAL-TESTS FOR BIVARIATE RESPONSE - INTERIM ANALYSES OF CLINICAL-TRIALS WITH BOTH EFFICACY AND SAFETY END-POINTS
GROUP SEQUENTIAL-TESTS FOR BIVARIATE RESPONSE - INTERIM ANALYSES OF CLINICAL-TRIALS WITH BOTH EFFICACY AND SAFETY END-POINTS
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DOI：
10.2307/2532195
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发表时间：
1993-09-01
期刊：
影响因子：
1.9
通讯作者：
TURNBULL, BW
中科院分区：
文献类型：
--
作者：
JENNISON, C;TURNBULL, BW
我们描述了双变量响应的组序列检验。测试是根据两个响应组成部分共同定义的，而不是通过单个汇总统计来定义的。当两种反应涉及治疗的不同方面时，这种方法是适当的；例如，人们可能希望证明一种新的治疗方法与现行标准一样有效和安全。我们提出了一个二元检验问题的公式，引入了满足第一类误差条件的组序列检验，并展示了如何找到保证指定功率的样本量。我们描述了如何用数值积分计算二元正态观测的群序列检验的性质。
We describe group sequential tests for a bivariate response. The tests are defined in terms of the two response components jointly, rather than through a single summary statistic. Such methods are appropriate when the two responses concern different aspects of a treatment; for example, one might wish to show that a new treatment is both as effective and as safe as the current standard. We present a formulation of the bivariate testing problem, introduce group sequential tests that satisfy Type I error conditions, and show how to find the sample size guaranteeing a specified power. We describe how properties of group sequential tests for bivariate normal observations can be computed by numerical integration.