240 citations
Counting papers with at most 25 authors, so collaboration author lists do not stand in for the people here.
- 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 · 2 filters
Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): Rationale and statistical concept of a meta-analytic study
Regina Stegherr, Jan Beyersmann, Valentine Jehl +4
The assessment of safety is an important aspect of the evaluation of new therapies in clinical trials, with analyses of adverse events being an essential part of this. Standard met…
Beyond p-values: a phase II dual-criterion design with statistical significance and clinical relevance
Satrajit Roychoudhury, Nicolas Scheuer, Beat Neuenschwander
Background: Well-designed phase II trials must have acceptable error rates relative to a pre-specified success criterion, usually a statistically significant p-value. Such standard…
Blinded sample size re-estimation in equivalence testing
Ekkehard Glimm, Lillian Yau, Heike Woehling
This paper investigates type I error violations that occur when blinded sample size reviews are applied in equivalence testing. We give a derivation which explains why such violati…
Bayesian leveraging of historical control data for a clinical trial with time-to-event endpoint
Satrajit Roychoudhury, Beat Neuenschwander
The recent 21st Century Cures Act propagates innovations to accelerate the discovery, development, and delivery of 21st century cures. It includes the broader application of Bayesi…
A Bayesian decision-theoretic approach to incorporate preclinical information into phase I oncology trials
Haiyan Zheng, Lisa V. Hampson
Leveraging preclinical animal data for a phase I first-in-man trial is appealing yet challenging. A prior based on animal data may place large probability mass on values of the dos…
Applying Meta-Analytic-Predictive Priors with the R Bayesian evidence synthesis tools
Sebastian Weber, Yue Li, John Seaman +2
Use of historical data in clinical trial design and analysis has shown various advantages such as reduction of within-study placebo-treated number of subjects and increase of study…