6 papers
Communicating results in trials with multiple hypotheses or adaptive design features
Elina Asikanius, Marcel Wolbers, Mouna Akacha +8
Over time, clinical trials have increasingly incorporated complex design and analysis elements such as interim analyses, adaptations, multiple endpoints, and sophisticated multipli…
Navigating the Landscape of Hierarchical Multi-Component Strategies: GPC, DOOR, and MOST
Mickaël De Backer, Johan Verbeeck, Vivian Lanius +5
There is a growing recognition of the importance to involve patients in every stage of drug development. This shift acknowledges that patients' perspectives, experiences, and prefe…
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…
Statistical Methodology Groups in the Pharmaceutical Industry
Jenny Devenport, Tobias Mielke, Mouna Akacha +10
Research and Development is the largest budget position in the pharmaceutical industry, with clinical trials being a critical, yet costly and time-consuming component to inform dec…
In silico clinical trials in drug development: a systematic review
Bohua Chen, Lucia Chantal Schneider, Christian Röver +15
In the context of clinical research, computational models have received increasing attention over the past decades. In this systematic review, we aimed to provide an overview of th…
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…