7 papers
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…