165 citations · 360 across the 19 of their papers we have counts for
23 papers
Testing for subgroup treatment effect consistency in the Cox model
Lukas Koletzko, Holger Dette, Björn Bornkamp +2
An overall treatment effect in a clinical trial may inadequately represent particular patient subgroups, creating uncertainty about whether a population-level efficacy conclusion c…
Randomization-based Inference for MCP-Mod
Lukas Pin, Oleksandr Sverdlov, Frank Bretz +1
Dose selection is critical in pharmaceutical drug development, as it directly impacts therapeutic efficacy and patient safety of a drug. The Generalized Multiple Comparison Procedu…
Futility analyses for the MCP-Mod methodology based on longitudinal models
Björn Bornkamp, Jie Zhou, Dong Xi +1
This article discusses futility analyses for the MCP-Mod methodology. Formulas are derived for calculating predictive and conditional power for MCP-Mod, which also cover the case w…
WATCH: A Workflow to Assess Treatment Effect Heterogeneity in Drug Development for Clinical Trial Sponsors
Konstantinos Sechidis, Sophie Sun, Yao Chen +8
This paper proposes a Workflow for Assessing Treatment effeCt Heterogeneity (WATCH) in clinical drug development targeted at clinical trial sponsors. WATCH is designed to address t…
Predicting subgroup treatment effects for a new study: Motivations, results and learnings from running a data challenge in a pharmaceutical corporation
Björn Bornkamp, Silvia Zaoli, Michela Azzarito +6
We present the motivation, experience and learnings from a data challenge conducted at a large pharmaceutical corporation on the topic of subgroup identification. The data challeng…
Eliciting judgements about dependent quantities of interest: The SHELF extension and copula methods illustrated using an asthma case study
Björn Holzhauer, Lisa V. Hampson, John Paul Gosling +8
Pharmaceutical companies regularly need to make decisions about drug development programs based on the limited knowledge from early stage clinical trials. In this situation, elicit…