4 papers
On the inclusion of non-concurrent controls in platform trials with an interim analysis
Pavla Krotka, Martin Posch, Marta Bofill Roig
The analysis of platform trials can be enhanced by utilizing non-concurrent controls. Since including this data might also introduce bias in the treatment effect estimators if time…
Clustering-Based Outcome Models for Clinical Studies: A Scoping Review
Johannes Vilsmeier, Fabian Eibensteiner, Franz König +6
This review provides a systematic overview of methods that combine covariate-based clustering of observational units (patients) with outcome models for clinical studies. We disting…
An Adaptive Phase II Trial Design for Dose Selection and Addition in Microfilarial Infections
Sonja Zehetmayer, Marta Bofill Roig, Fabrice Lotola Mougeni +3
We propose a frequentist adaptive phase 2 trial design to evaluate the safety and efficacy of three treatment regimens (doses) compared to placebo for four types of helminth (worm)…
Statistical modeling to adjust for time trends in adaptive platform trials utilizing non-concurrent controls
Pavla Krotka, Martin Posch, Mohamed Gewily +2
Utilizing non-concurrent control data (NCC) in the analysis of late-entering arms in platform trials has recently received considerable attention. While incorporating NCC can lead…