Improved repeated confidence bounds in trials with a maximal goal

Improved repeated confidence bounds in trials with a maximal goal
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DOI:
10.1002/bimj.200390014
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发表时间:
2003-01-01
影响因子:
1.7
通讯作者:
Bauer, P
Bauer, P
中科院分区:
生物学3区
文献类型:
--
作者:
Brannath, W;König, F;Bauer, P

文献摘要

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重复置信区间可以在灵活的成组序贯设计的每次中期分析时计算,而无需使用预先计划的停止规则停止试验。然而,通常有一个最大目标,如果达到这个目标,试验肯定会停止。这个导出了一个极大停止准则,在遵守该准则时,重复置信区间是严格保守的.在这种情况下,提出了一种一致改进单侧重复置信区间的修正.当在中期分析中达到最大目标时,它保留了监测特征,并导致一致较小的间隔。该修正适用于两阶段设计,并适用于多阶段试验。改善的程度是量化的两个简单的场景。
Repeated confidence intervals can be computed at every interim analysis of a flexible group sequential design without the need to stop the trial with a pre-planned stopping rule. Often, however, there is a maximal goal such that the trial is surely stopped if this goal is reached. This. induces a maximal stopping rule, and repeated confidence intervals are strictly conservative, when adhering to it. A modification is proposed which uniformly improves the one sided repeated confidence interval in such a situation. It preserves the monitoring character, and leads to uniformly smaller intervals, when reaching the maximal goal at an interim analysis. The modification is worked out for two stage designs and is indicated for multi-stage trials. The extent of the improvement is quantified for two simple scenarios.