ArticleBMC medical research methodology2025
Assessing the replicability of RCTs in RWE emulations.
Article in BMC medical research methodology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Authors and funding
5 authors.
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No grant is acknowledged in the PubMed record.
Abstract
backgroundThe standard regulatory approach to assess replication success is the two-trials rule, requiring both the original and the replication study to be significant with effect estimates in the same direction. The sceptical p-value was recently presented as an alternative method for the statistical assessment of the replicability of study results.
methodsWe review the statistical properties of the sceptical p-value and compare those to the two-trials rule. We extend the methodology to non-inferiority trials and describe how to invert the sceptical p-value to obtain confidence intervals. We illustrate the performance of the different methods using real-world evidence emulations of randomized controlled trials (RCTs) conducted within the RCT DUPLICATE initiative.
resultsThe sceptical p-value depends not only on the two p-values, but also on sample size and effect size of the two studies. It can be calibrated to have the same Type-I error rate as the two-trials rule, but has larger power to detect an existing effect. In the application to the results from the RCT DUPLICATE initiative, the sceptical p-value leads to qualitatively similar results than the two-trials rule, but tends to show more evidence for treatment effects compared to the two-trials rule.
conclusionThe sceptical p-value represents a valid statistical measure to assess the replicability of study results and is useful in the context of real-world evidence emulations.
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