6 papers
A Bayesian Phase I/II basket design with robust information borrowing to identify subtrial-specific optimal biological doses
Zhi Cao, Haiyan Zheng, Pavel Mozgunov
The objective of modern early oncology dose-finding is to identify an optimal biological dose (OBD), rather than simply the maximum tolerated dose. In basket trials, the dose-toxic…
U-DESPE: a Bayesian Utility-based methodology for dosing regimen optimization in early-phase oncology trials based on Dose-Exposure, Safety, Pharmacodynamics, Efficacy
Anaïs Andrillon, Sandrine Micallef, Moreno Ursino +2
With the development of novel therapies such as molecularly targeted agents and immunotherapy, the maximum tolerated dose paradigm that "more is better" does not necessarily hold a…
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…
Robust Bayesian hierarchical models for basket trials enabling joint evaluation of toxicity and efficacy
Zhi Cao, Pavel Mozgunov, Haiyan Zheng
Basket trials have gained increasing attention for their efficiency, as multiple patient subgroups are evaluated simultaneously. Conducted basket trials focus primarily on establis…
Design specification of Partial Ordering Continual Reassessment Method based on consistency conditions
Weishi Chen, Pavel Mozgunov
The study of combinations of drugs/drug-schedules gained increasing attention in various therapeutic areas recently. In oncology, the aim of phase I combination clinical trial is t…
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…