13 citations · 16 across the 8 of their papers we have counts for
8 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…
Coping with Information Loss and the Use of Auxiliary Sources of Data: A Report from the NISS Ingram Olkin Forum Series on Unplanned Clinical Trial Disruptions
Silvia Calderazzo, Sergey Tarima, Carissa Reid +9
Clinical trials disruption has always represented a non negligible part of the ending of interventional studies. While the SARS-CoV-2 (COVID-19) pandemic has led to an impressive a…
Tutorial: Effective visual communication for the quantitative scientist
Marc Vandemeulebroecke, Mark Baillie, Alison Margolskee +1
Effective visual communication is a core competency for pharmacometricians, statisticians, and more generally any quantitative scientist. It is essential in every step of a quantit…