ON THE DESIGN AND ANALYSIS OF RANDOMIZED CLINICAL-TRIALS WITH MULTIPLE END-POINTS
ON THE DESIGN AND ANALYSIS OF RANDOMIZED CLINICAL-TRIALS WITH MULTIPLE END-POINTS
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DOI：
10.2307/2532599
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发表时间：
1993-03-01
期刊：
影响因子：
1.9
通讯作者：
POCOCK, SJ
中科院分区：
文献类型：
--
作者：
TANG, DI;GELLER, NL;POCOCK, SJ
本文探讨了在临床试验结果分析和报告中减少显著性检验次数的一些方法。重点放在设计和分析临床试验，以检查有关多个终点的复合假设，并将此多终点方法与组序贯方法相结合。考虑了四种复合假设的方法：普通最小二乘和广义最小二乘方法，这两种方法都是由奥布莱恩（1984年，生物统计学40，1079-1087）提出的，是对这些方法的一种新的修改，以及近似似然比检验，由唐、格尼科和盖勒（1989年，生物统计学76，577-583）提出。这些扩展用于组顺序使用。特别是，模拟是用来产生临界值和序列的名义上的显着性水平的近似似然比检验，这不是正态分布。给出了一个例子，并讨论了所建议的方法的相对优点。
This paper considers some methods for reducing the number of significance tests undertaken when analyzing and reporting results of clinical trials. Emphasis is placed on designing and analyzing clinical trials to examine a composite hypothesis concerning multiple endpoints and combining this multiple endpoint methodology with group sequential methodology. Four methods for composite hypotheses are considered: an ordinary least squares and a generalized least squares approach both due to O'Brien (1984, Biometrics 40, 1079-1087), a new modification of these, and an approximate likelihood ratio test, due to Tang, Gnecco, and Geller (1989, Biometrika 76, 577-583). These are extended for group sequential use. In particular, simulation is used to generate critical values and sequences of nominal significance levels for the approximate likelihood ratio test, which is not normally distributed. An example is given and the relative merits of the suggested approaches are discussed.