Replication studies are increasingly conducted to assess the credibility of scientific findings. Most of these replication attempts target studies with a superiority design, and 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.
翻译:重复研究日益被用于评估科学发现的可靠性。大多数此类重复尝试针对的是优效性设计的研究,而针对等效性等替代设计类型的重复研究分析方法尚不充分。为填补这一空白,我们提出了两种方法——双试验法则和怀疑TOST程序——它们改编自优效性场景中使用的现有方法。两种方法具有相同的总体I类错误率,但怀疑TOST程序即使在原始或重复研究结果不显著时也能允许重复成功,这导致了更大的项目把握度以及相关操作特性上的其他差异。两种方法均可基于原始研究结果用于重复研究的样本量计算。我们将这两种方法应用于“重复性项目:癌症生物学”的数据中。