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富集窗方法作为处理抗抑郁药临床试验中安慰剂反应的一种手段。

The enrichment window approach as a means of dealing with placebo response in antidepressant clinical trials.

机构信息

Lilly Research Labs, Indianapolis, Indiana, USA.

出版信息

Clin Pharmacol Ther. 2010 Nov;88(5):592-4. doi: 10.1038/clpt.2010.222.

DOI:10.1038/clpt.2010.222
PMID:20959845
Abstract

In this issue, Merlo-Pich et al. present an enrichment-window approach that identifies sites with aberrant mean placebo responses and excludes data from those sites so as to improve drug-placebo discrimination in antidepressant clinical trials. The method appears to increase the signal in situations in which the test drug is better than placebo. However, confirmation of its impact on the rate of false-positive results is needed before the method can be used prospectively.

摘要

在本期中,Merlo-Pich 等人提出了一种富集窗口方法,该方法可以识别出安慰剂反应异常的位点,并排除这些位点的数据,从而提高抗抑郁药临床试验中药物与安慰剂的区分度。该方法似乎可以在试验药物优于安慰剂的情况下增加信号。然而,在该方法可以被前瞻性使用之前,需要确认其对假阳性结果发生率的影响。

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