Asymmetric group sequential boundaries for monitoring clinical trials
Asymmetric group sequential boundaries for monitoring clinical trials
复制标题
用于监测临床试验的不对称组顺序边界
DOI：
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发表时间：
1982
期刊：
影响因子：
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通讯作者：
J. Ware
中科院分区：
文献类型：
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作者：
D. DeMets;J. Ware
本文提出了一种组序贯方法，用于临床试验中累积数据的定期分析，这些临床试验基本上是单侧的，如治疗-安慰剂研究。当治疗无效或有害时，建议的边界保留了DeMets & Ware（1980）先前描述的程序的早期停止特性，但纳入了奥布莱恩& Fleming（1979）提出的模型的更严格要求，即早期拒绝零假设，支持治疗。
A group sequential method is proposed for the periodic analysis of accumulating data in clinical trials which are essentially one-sided as in treatment-placebo studies. The proposed boundaries retain the early stopping properties of the procedure described previously by DeMets & Ware (1980) when treatment appears to be ineffective or harmful but incorporate the more stringent requirements of the model proposed by O'Brien & Fleming (1979) for early rejection of the null hypothesis in favour of treatment.