Papers › Assessing the replicability of RCTs in RWE emulations
Assessing the replicability of RCTs in RWE emulations
Jeanette Köppe, Charlotte Micheloud, Stella Erdmann, Rachel Heyard, Leonhard Held
The archive published only this paper's code-link row. Authors, date and abstract are from arXiv's metadata (CC0), read from the Kaggle arXiv metadata snapshot of 2026-09-12 where its title matched the archive's; the title is the archive's.
Background: The 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. Methods: We 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. Results: The 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. Conclusion: The sceptical p-value represents a valid statistical measure to assess the replicability of study results and is especially useful in the context of real-world evidence emulations.
Code
Repository list and official/mentioned flags are the archive's, frozen 2025-07-28. Reachability, where shown, is from one Syntology probe window (2026-09-16 to 2026-09-18); repositories not probed show nothing. GitHub stars are not tracked.
Code Syntology ran Syntology
Not run by Syntology. Nothing on this page verifies that the listed code works.
Results from the paper archive 2025-07-28
No leaderboard rows for this paper in the archive.
Report a problem or propose a change · a person checks every report against the paper or source before anything changes; decisions are listed on /corrections