论文标题

等效研究的复制

The replication of equivalence studies

论文作者

Micheloud, Charlotte, Held, Leonhard

论文摘要

越来越多地进行复制研究以评估科学发现的信誉。这些复制尝试中的大多数都以优越的设计为目标研究,但是缺乏关于用替代类型的设计(例如等效性)进行复制研究的方法。为了填补这一空白,我们提出了两种方法,即两试规则和怀疑的tost程序,改编自优势设置中使用的方法。两种方法都具有相同的总体I级错误率,但是即使对于非显着的原始或复制研究,怀疑的TOST程序也允许复制成功。这会导致更大的项目能力和其他相关操作特征的差异。两种方法都可以根据原始方法的结果来用于复制研究的样本量计算。这两种方法应用于可重复性项目的数据:癌症生物学。

Replication studies are increasingly conducted to assess the credibility of scientific findings. Most of these replication attempts target studies with a superiority design, but there is a lack of methodology regarding the analysis of replication studies with alternative types of designs, such as equivalence. In order to fill this gap, we propose two approaches, the two-trials rule and the sceptical TOST procedure, adapted from methods used in superiority settings. Both methods have the same overall Type-I error rate, but the sceptical TOST procedure allows replication success even for non-significant original or replication studies. This leads to a larger project power and other differences in relevant operating characteristics. Both methods can be used for sample size calculation of the replication study, based on the results from the original one. The two methods are applied to data from the Reproducibility Project: Cancer Biology.

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