8 papers · 1 filter
Bayes Factor Group Sequential Designs
Samuel Pawel, Leonhard Held
The Bayes factor, the data-based updating factor from prior to posterior odds, is a principled measure of relative evidence for two competing hypotheses. It is naturally suited to…
Balancing Evidentiary Value and Sample Size of Adaptive Designs with Application to Animal Experiments
Leonhard Held, Fadoua Balabdaoui, Saverio Fontana +1
Reducing the number of experimental units is one of the three pillars of the 3R principles (Replace, Reduce, Refine) in animal research. At the same time, statistical error rates n…
Stabilizing Thompson Sampling with Null Hypothesis Bayesian Response-Adaptive Randomization
Samuel Pawel, Leonhard Held
Response-adaptive randomization (RAR) methods can be used to adapt randomization probabilities based on accumulating data, aiming to increase the probability of allocating patients…
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…
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…