临床试验的停止规则。

Stopping rules for clinical trials.

作者信息

Freedman L S, Lowe D, Macaskill P

出版信息

Stat Med. 1983 Apr-Jun;2(2):167-74. doi: 10.1002/sim.4780020210.

DOI:10.1002/sim.4780020210

Abstract

We describe a new method of formulating stopping rules for clinical trials, one that incorporates opinion on what difference is clinically important. We compare the method with conventional group sequential designs and illustrate it by application to a study of Pancuronium Bromide for prevention of haemorrhage in pre-term infants.

摘要

我们描述了一种为临床试验制定终止规则的新方法，该方法纳入了关于何种差异具有临床重要性的观点。我们将该方法与传统的序贯设计进行比较，并通过将其应用于一项关于潘库溴铵预防早产儿出血的研究来说明这一方法。