STOPPING A CLINICAL-TRIAL VERY EARLY BASED ON UNPLANNED INTERIM ANALYSES - A GROUP SEQUENTIAL APPROACH
STOPPING A CLINICAL-TRIAL VERY EARLY BASED ON UNPLANNED INTERIM ANALYSES - A GROUP SEQUENTIAL APPROACH
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DOI：
10.2307/2533015
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发表时间：
1995-09-01
期刊：
影响因子：
1.9
通讯作者：
EMERSON, SS
中科院分区：
文献类型：
--
作者：
EMERSON, SS
在进行临床试验时，意外的高毒性率可能导致研究人员想要提前终止试验，即使没有正式的停止规则。一个这样的临床试验的经验是作为一个例子，在组序贯方法可以应用于决定停止研究，以及在报告临床试验的结果。然后将这种方法与贝叶斯分析进行比较。
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.