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基于非计划的期中分析提前终止临床试验:一种序贯设计方法。

Stopping a clinical trial very early based on unplanned interim analyses: a group sequential approach.

作者信息

Emerson S S

机构信息

Arizona Cancer Center, University of Arizona, Tucson 85724, USA.

出版信息

Biometrics. 1995 Sep;51(3):1152-62.

PMID:7548699
Abstract

In the conduct of a clinical trial, unexpectedly high rates of toxicity may cause a researcher to want to terminate the trial early even though no formal stopping rule had been specified. The experience of one such clinical trial is used as an example of the ways in which group sequential methodology can be applied in deciding to stop the study, as well as in reporting the results of the clinical trial. This approach is then compared to a Bayesian analysis.

摘要

在进行一项临床试验时,意外出现的高毒性发生率可能会导致研究人员想要提前终止试验,即使之前并未规定正式的停止规则。以这样一项临床试验的经验为例,说明如何应用序贯分组方法来决定停止研究以及报告临床试验结果。然后将这种方法与贝叶斯分析进行比较。

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