ABSTRACT

Stopping for futility is a useful tool in a clinical trial. It is widely used in single-arm trials in oncology and in many two-arm trials. We review three stopping rules for futility. We give recommendations for the optimal timing of futility looks in two-stage trials in terms of the information fraction and the probability of stopping under the alternative hypothesis. We discuss futility stopping in trials with substantial uncertainty about the variability of the outcome and in crossover trials.

中文翻译：

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临床试验中的无效停止、优化和实际考虑

摘要

因无用而停止是临床试验中的有用工具。它广泛用于肿瘤学的单臂试验和许多双臂试验。我们审查了三个无效的停止规则。我们根据信息分数和在备择假设下停止的概率，就两阶段试验中无效的最佳时机提出建议。我们讨论了在结果的可变性和交叉试验中存在很大不确定性的试验中的无效停止。