Is it possible to claim efficacy if one of two trials is significant while the other just shows a trend?
Is it possible to claim efficacy if one of two trials is significant while the other just shows a trend?
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DOI：
10.1177/009286150203600416
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发表时间：
2002-10-01
影响因子：
--
通讯作者：
Rosenkranz, G
中科院分区：
文献类型：
--
作者：
Rosenkranz, G
本文探讨了允许基于两项关键临床试验结果的新药功效声明的可能性，如果其中一项试验在通常意义上是重要的，而另一项试验只是显示了正确方向的趋势。我们表明，有可能选择I型误差，使单个试验能够实现这一目标，而不会大幅增加整体I型误差。
This note explores the possibility of allowing an efficacy claim for a new drug based upon the results of two pivotal clinical trials if one trial is significant in the usual sense while the other just shows a trend in the right direction. We show that it is possible to select the type I errors that enable the individual trials to achieve this goal without a substantial increase in the overall type I error.