Clinical trial designs based on sequential conditional probability ratio tests and reverse stochastic curtailing
Clinical trial designs based on sequential conditional probability ratio tests and reverse stochastic curtailing
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DOI：
10.2307/3109774
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发表时间：
1998-06-01
期刊：
影响因子：
1.9
通讯作者：
Kutner, MH
中科院分区：
文献类型：
--
作者：
Tan, M;Xiong, XP;Kutner, MH
提出了一种基于序列条件概率比检验的群序列方法，并证明了该方法具有实践所要求的保守性。我们还建议计算不协调概率，即在试验计划结束时，顺序检验的结论与固定样本检验不同的概率，认识到这种概率可能很大，即使顺序检验与研究计划结束时的固定样本量检验具有相同的大小和威力。此外，我们还证明了该方法可以作为一种随机裁剪工具。因此，该方法既适用于计划外的中期分析，也适用于根据数据趋势认为必要的分析，几乎不会增加第一类误差，但它比通常的随机缩减更不保守。该方法通过交互式计算机程序实现。
We propose a group sequential method based on the sequential conditional probability ratio test and show that it has the conservatism desired in practice. We also propose calculating the discordant probability, that is, the probability that the sequential test concludes differently from a fixed-sample test at the planned end of the trial, recognizing that this probability could be substantial, even if the sequential test has the same size and power as the fixed-sample size test at the planned end of the study. In addition, we show that the proposed method can be used as a stochastic curtailing tool. Thus, the method accommodates unplanned interim analyses as well as those deemed necessary based on data trends, virtually without inflating the type I error, but it is less conservative than the usual stochastic curtailing. The method is implemented through an interactive computer program.