Early phase clinical trials
Early phase studies are often designed and implemented without substantive statistical input. The 3+3 maximum tolerated dose finding design being a classic example. This group aims to improve statistical aspects of early phase studies by bridging the gap between clinical trialists using traditional designs and modern statistical methodologists with many improvements to offer.
We are interested in reaching a consensus within the statistical community of which modern methods should be regarded as standard, and communicating these methods to a wider audience through training and education to increase their use in real-life trials.
Collaborative research enables us to consolidate our knowledge and share expertise. Our research section seeks to undertake collaborative working to promote high quality research by tackling discipline specific issues.
If you would like to be part of a research section or wish to find out more please email the NIHR Statistics Group.
Section leaders
Christina Yap
The Institute of Cancer Research
Simon Bond
Cambridge Clinical Trials Unit
Section committee members
Emily Alger
The Institute of Cancer Research
Haiyan Zheng
University of Bath
Pavel Mozgunov
University of Cambridge
Graham Wheeler
Imperial College London
Previous events
Implementing novel designs in early phase dose-finding trials
CONCORDE: a phase I platform trial using the TiTE-CRM design
Flexible early-phase design for drug combination studies
Implementing a Bivariate Continual Reassessment Method in a Non-Oncology First In Human Trial
NIHR Statistics Early Phase Trials Group Meeting 2019
Second Workshop of the NIHR Statistics Group’s Early Phase Trials Research Section
Early phase clinical trials Publications
How to design a dose-finding study using the Continual Reassessment Method
BMC Medical Research Methodology, in press
Embracing model-based designs for dose-finding trials
British Journal of Cancer advance online publication 29 June 2017
Dose-finding trials are essential to drug development as they establish recommended doses for later-phase testing. We aim to motivate wider use of model-based designs for dose finding, such as the continual reassessment method