Group sequential methods for clinical trials with a one-sided hypothesis
Group sequential methods for clinical trials with a one-sided hypothesis
复制标题
具有片面假设的临床试验的分组序贯方法
DOI：
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发表时间：
1980
期刊：
影响因子：
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通讯作者：
J. Ware
中科院分区：
文献类型：
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作者：
D. DeMets;J. Ware
摘要Pocock(1977)最近提出了用于临床试验序贯分析的组序贯方法。然而，这些方法的目的是针对双向替代方案测试无效假设，而许多针对标准疗法的新疗法试验都有单方面替代方案。继续试验以确定新疗法是否真的不如标准疗法可能是不合适的，甚至是不道德的。在这篇论文中，考虑了对检验片面假设的临床试验进行序贯监测的分组序贯方法的三种可能的修改。
SUMMARY Pocock (1977) has recently proposed group sequential methods for sequential analysis of clinical trials. However, these methods are intended to test a null hypothesis against a twosided alternative, and many trials of a new therapy against a standard have one-sided alternatives. Continuation of the trial to determine whether the new therapy is actually inferior to the standard therapy may be inappropriate or even unethical. In the present paper, three possible modifications of the group sequential method for sequential monitoring of clinical trials testing a one-sided hypothesis are considered.