32 citations · 65 across the 8 of their papers we have counts for
8 papers
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…
The assessment of replicability using the sum of p-values
Leonhard Held, Samuel Pawel, Charlotte Micheloud
Statistical significance of both the original and the replication study is a commonly used criterion to assess replication attempts, also known as the two-trials rule in drug devel…
Replication of "null results" -- Absence of evidence or evidence of absence?
Samuel Pawel, Rachel Heyard, Charlotte Micheloud +1
In several large-scale replication projects, statistically non-significant results in both the original and the replication study have been interpreted as a "replication success".…
Assessing replicability with the sceptical p-value: Type-I error control and sample size planning
Charlotte Micheloud, Fadoua Balabdaoui, Leonhard Held
We study a statistical framework for replicability based on a recently proposed quantitative measure of replication success, the sceptical -value. A recalibration is proposed to…
The replication of equivalence studies
Charlotte Micheloud, Leonhard Held
Replication studies are increasingly conducted to assess the credibility of scientific findings. Most of these replication attempts target studies with a superiority design, but th…
Combining Evidence from Clinical Trials in Conditional or Accelerated Approval
Manja Deforth, Charlotte Micheloud, Kit C Roes +1
Conditional (European Medicines Agency) or accelerated (U.S. Food and Drug Administration) approval of drugs allow earlier access to promising new treatments that address unmet med…
The assessment of replication success based on relative effect size
Leonhard Held, Charlotte Micheloud, Samuel Pawel
Replication studies are increasingly conducted in order to confirm original findings. However, there is no established standard how to assess replication success and in practice ma…
Power Calculations for Replication Studies
Charlotte Micheloud, Leonhard Held
The reproducibility crisis has led to an increasing number of replication studies being conducted. Sample sizes for replication studies are often calculated using conditional power…