4 papers
Exhausting the type I error level in event-driven group-sequential designs with a closed testing procedure for progression-free and overall survival
Moritz Fabian Danzer, Kaspar Rufibach, Jan Beyersmann +1
In oncological clinical trials, overall survival (OS) is the gold-standard endpoint, but long follow-up and treatment switching can delay or dilute detectable effects. Progression-…
Correcting for sampling variability in maximum likelihood-based one-sample log-rank tests
Moritz Fabian Danzer, Rene Schmidt
Single-arm studies in the early development phases of new treatments are not uncommon in the context of rare diseases or in paediatrics. If an assessment of efficacy is to be made…
Confirmatory Adaptive Hypothesis Tests in Markovian Illness-Death Models
Rene Schmidt, Moritz Fabian Danzer
Classic adaptive designs for time-to-event trials are based on the log-rank statistic and its increments. Thereby, only information from the time-to-event endpoint on which the sel…
Adaptive weight selection for time-to-event data under non-proportional hazards
Moritz Fabian Danzer, Ina Dormuth
When planning a clinical trial for a time-to-event endpoint, we require an estimated effect size and need to consider the type of effect. Usually, an effect of proportional hazards…