240 citations
- Universitätsmedizin GöttingenDE13 papers
- Medical University of ViennaAT10 papers
- Roche (Switzerland)CH10 papers
- University of GöttingenDE9 papers
- Pfizer (United States)US6 papers
- Tris Pharma (United States)US6 papers
- Lancaster UniversityGB5 papers
- MRC Biostatistics UnitGB5 papers
- Novartis (United States)US5 papers
- University Hospital MagdeburgDE5 papers
- Boehringer Ingelheim (Germany)DE4 papers
- Newcastle UniversityGB4 papers
6 papers · 1 filter
On model-based time trend adjustments in platform trials with non-concurrent controls
Marta Bofill Roig, Pavla Krotka, Carl-Fredrik Burman +9
Platform trials can evaluate the efficacy of several treatments compared to a control. The number of treatments is not fixed, as arms may be added or removed as the trial progresse…
Combining cytotoxic agents with continuous dose levels in seamless phase I-II clinical trials
José L. Jiménez, Mourad Tighiouart
Phase I-II cancer clinical trial designs are intended to accelerate drug development. In cases where efficacy cannot be ascertained in a short period of time, it is common to divid…
Geometric approaches to assessing the numerical feasibility for conducting matching-adjusted indirect comparisons
Ekkehard Glimm, Lillian Yau
We discuss how to handle matching-adjusted indirect comparison (MAIC) from a data analyst's perspective. We introduce several multivariate data analysis methods to assess the appro…
Inverse probability of censoring weighting for visual predictive checks of time-to-event models with time-varying covariates
Christian Bartels, Thomas Dumortier
When constructing models to summarize clinical data to be used for simulations, it is good practice to evaluate the models for their capacity to reproduce the data. This can be don…
Decision rules for identifying combination therapies in open-entry, randomized controlled platform trials
Elias Laurin Meyer, Peter Mesenbrink, Cornelia Dunger-Baldauf +3
Platform trials have become increasingly popular for drug development programs, attracting interest from statisticians, clinicians and regulatory agencies. Many statistical questio…
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…