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.
翻译:复制研究日益被用于评估科学发现的可靠性。大多数复制尝试针对的是优效性设计的研究,但对于其他类型设计(如等效性)的复制研究分析方法尚存在不足。为填补这一空白,我们提出了两种方法:双试验规则和怀疑性TOST程序,这两种方法改编自优效性设置中使用的方法。两种方法具有相同的总体I类错误率,但怀疑性TOST程序即使在原始或复制研究不显著的情况下也能实现复制成功。这导致了更大的项目检验效能以及相关操作特征中的其他差异。两种方法均可基于原始研究的结果用于复制研究的样本量计算。这两种方法被应用于来自《可重复性项目:癌症生物学》的数据。