3 papers
stat.AP2026
Edgington's Combination Method for Two-Study Meta-Analysis: An Empirical Evaluation in 1226 Meta-Analyses
Samuel Pawel, Saverio Fontana, Jinyu Chen +6
Two-study meta-analyses are common in evidence synthesis but pose major statistical challenges. With only two studies, the between-study variance cannot be reliably estimated, rend…
stat.ME2025
Combined P-value Functions for Compatible Effect Estimation and Hypothesis Testing in Drug Regulation
Samuel Pawel, Małgorzata Roos, Leonhard Held
The two-trials rule in drug regulation requires statistically significant results from two pivotal trials to demonstrate efficacy. However, it is unclear how the effect estimates f…
stat.ME2024
Assessing the replicability of RCTs in RWE emulations
Jeanette Köppe, Charlotte Micheloud, Stella Erdmann +2
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 effe…