37 citations · 50 across the 20 of their papers we have counts for
25 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…
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…
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…
Partial Ordering Bayesian Logistic Regression Model for Phase I Combination Trials and Computationally Efficient Approach to Operational Prior Specification
Weishi Chen, Pavel Mozgunov
Recent years have seen increased interest in combining drug agents and/or schedules. Several methods for Phase I combination-escalation trials are proposed, among which, the partia…
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…
Design of platform trials with a change in the control treatment arm
Peter Greenstreet, Thomas Jaki, Alun Bedding +1
Platform trials are a more efficient way of testing multiple treatments compared to running separate trials. In this paper we consider platform trials where, if a treatment is foun…
A preplanned multi-stage platform trial for discovering multiple superior treatments with control of FWER and power
Peter Greenstreet, Thomas Jaki, Alun Bedding +1
There is a growing interest in the implementation of platform trials, which provide the flexibility to incorporate new treatment arms during the trial and the ability to halt treat…
Bayesian sample size determination in basket trials borrowing information between subsets
Haiyan Zheng, Michael J. Grayling, Pavel Mozgunov +2
Basket trials are increasingly used for the simultaneous evaluation of a new treatment in various patient subgroups under one overarching protocol. We propose a Bayesian approach t…
A multi-arm multi-stage platform design that allows pre-planned addition of arms while still controlling the family-wise error
Peter Greenstreet, Thomas Jaki, Alun Bedding +2
There is growing interest in platform trials that allow for adding of new treatment arms as the trial progresses as well as being able to stop treatments part way through the trial…
A Comparison of Various Aggregation Functions in Multi-Criteria Decision Analysis for Drug Benefit-Risk Assessment
Tom Menzies, Gaelle Saint-Hilary, Pavel Mozgunov
Multi-criteria decision analysis (MCDA) is a quantitative approach to the drug benefit-risk assessment (BRA) which allows for consistent comparisons by summarising all benefits and…
A Comparison of Model-Free Phase I Dose Escalation Designs for Dual-Agent Combination Therapies
Helen Yvette Barnett, Matthew George, Donia Skanji +3
It is increasingly common for therapies in oncology to be given in combination. In some cases, patients can benefit from the interaction between two drugs, although often at the ri…
A Seamless Phase I/II Platform Design with a Time-To-Event Efficacy Endpoint for Potential COVID-19 Therapies
Thomas Jaki, Helen Barnett, Andrew Titman +1
In the search for effective treatments for COVID-19, initial emphasis has been on re-purposed treatments. To maximise the chances of finding successful treatments, novel treatments…
Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs
Thomas Burnett, Pavel Mozgunov, Philip Pallmann +3
Adaptive designs for clinical trials permit alterations to a study in response to accumulating data in order to make trials more flexible, ethical and efficient. These benefits are…
Improving Safety of the Continual Reassessment Method via a Modified Allocation Rule
Pavel Mozgunov, Thomas Jaki
This paper proposes a novel criterion for the allocation of patients in Phase~I dose-escalation clinical trials aiming to find the maximum tolerated dose (MTD). Conventionally, usi…
An information-theoretic Phase I/II design for molecularly targeted agents that does not require an assumption of monotonicity
Pavel Mozgunov, Thomas Jaki
For many years Phase I and Phase II clinical trials were conducted separately, but there was a recent shift to combine these Phases. While a variety of Phase~I/II model-based desig…
A Benchmark for Dose Finding Studies with Continuous Outcomes
Pavel Mozgunov, Thomas Jaki, Xavier Paoletti
An important tool to evaluate the performance of any design is an optimal benchmark proposed by O'Quigley and others (2002, Biostatistics 3(1), 51-56) that provides an upper bound…
A review of the deterministic and diffusion approximations for stochastic chemical reaction networks
Pavel Mozgunov, Marco Beccuti, Andras Horvath +3
This work reviews deterministic and diffusion approximations of the stochastic chemical reaction networks and explains their applications. We discuss the added value the diffusion…
An information-theoretic approach for selecting arms in clinical trials
Pavel Mozgunov, Thomas Jaki
The question of selecting the "best" amongst different choices is a common problem in statistics. In drug development, our motivating setting, the question becomes, for example: wh…
Loss Functions in Restricted Parameter Spaces and Their Bayesian Applications
Pavel Mozgunov, Thomas Jaki, Mauro Gasparini
Squared error loss remains the most commonly used loss function for constructing a Bayes estimator of the parameter of interest. However, it can lead to sub-optimal solutions when…