From the 1 of 11 linked papers with an AI index.
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Combined P-value Functions for Compatible Effect Estimation and Hypothesis Testing in Drug Regulation
Samuel Pawel, MaÅgorzata 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…
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…
A comparison of combined p-value functions for meta-analysis
Leonhard Held, Felix Hofmann, Samuel Pawel
P-value functions are modern statistical tools that unify effect estimation and hypothesis testing and can provide alternative point and interval estimates compared to standard met…