7 papers · 1 filter
Using joint models in phase I dose-finding designs in oncology: considerations for frequentist approaches
Xijin Chen, Pavel Mozgunov, Richard D. Baird +1
Dose-finding trials for oncology studies are traditionally designed to assess safety in the early stages of drug development. With the rise of molecularly targeted therapies and im…
A multi-arm multi-stage design for trials with all pairwise testing
Peter Greenstreet, Thomas Jaki, Alun Bedding +1
Multi-arm multi-stage (MAMS) trials have gained popularity to enhance the efficiency of clinical trials, potentially reducing both duration and costs. This paper focuses on designi…
Making all pairwise comparisons in multi-arm clinical trials without control treatment
Thomas Burnett, Thomas Jaki
The standard paradigm for confirmatory clinical trials is to compare experimental treatments with a control, for example the standard of care or a placebo. However, it is not alway…
How to Add Baskets to an Ongoing Basket Trial with Information Borrowing
Libby Daniells, Pavel Mozgunov, Helen Barnett +2
Basket trials test a single therapeutic treatment on several patient populations under one master protocol. A desirable adaptive design feature in these studies may be the incorpor…
Next generation clinical trials: Seamless designs and master protocols
Abigail Burdon, Thomas Jaki, Xijin Chen +3
Background: Drug development is often inefficient, costly and lengthy, yet it is essential for evaluating the safety and efficacy of new interventions. Compared with other disease…
Bayesian Model Averaging for Partial Ordering Continual Reassessment Methods
Luka Kovacevic, Thomas Jaki, Helen Barnett +1
Phase I clinical trials are essential to bringing novel therapies from chemical development to widespread use. Traditional approaches to dose-finding in Phase I trials, such as the…