165 citations · 312 across the 16 of their papers we have counts for
8 papers · 1 filter
On relations between the Cochran--Mantel--Haenszel test and Augmented Inverse Probability Weighting
Ekkehard Glimm
This note revisits the Cochran-Mantel-Haenszel (CMH) test in light of the increasing use of causal inference methods in clinical trials. It shows that the CMH test statistic can be…
Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints
Elias Laurin Meyer, Peter Mesenbrink, Nicholas A. Di Prospero +5
Non-alcoholic steatohepatitis (NASH) is the progressive form of nonalcoholic fatty liver disease (NAFLD) and a disease with high unmet medical need. Platform trials provide great b…
CohortPlat: Simulation of cohort platform trials investigating combination therapies
Elias Laurin Meyer, Peter Mesenbrink, Cornelia Dunger-Baldauf +2
Platform trials have gained a lot of attention recently as a possible remedy for time-consuming classical two-arm randomized controlled trials, especially in early phase drug devel…
Geometric approaches to assessing the numerical feasibility for conducting matching-adjusted indirect comparisons
Ekkehard Glimm, Lillian Yau
We discuss how to handle matching-adjusted indirect comparison (MAIC) from a data analyst's perspective. We introduce several multivariate data analysis methods to assess the appro…
Decision rules for identifying combination therapies in open-entry, randomized controlled platform trials
Elias Laurin Meyer, Peter Mesenbrink, Cornelia Dunger-Baldauf +3
Platform trials have become increasingly popular for drug development programs, attracting interest from statisticians, clinicians and regulatory agencies. Many statistical questio…
Blinded sample size re-estimation in equivalence testing
Ekkehard Glimm, Lillian Yau, Heike Woehling
This paper investigates type I error violations that occur when blinded sample size reviews are applied in equivalence testing. We give a derivation which explains why such violati…
Confidence intervals with maximal average power
Christian Bartels, Johanna Mielke, Ekkehard Glimm
We propose a frequentist testing procedure that maintains a defined coverage and is optimal in the sense that it gives maximal power to detect deviations from a null hypothesis whe…
Group sequential designs for negative binomial outcomes
Tobias Mütze, Ekkehard Glimm, Heinz Schmidli +1
Count data and recurrent events in clinical trials, such as the number of lesions in magnetic resonance imaging in multiple sclerosis, the number of relapses in multiple sclerosis,…