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. We aim to communicate 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 join a working group committee or wish to find out more, please email the NIHR Statistics Group.
Group leaders
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Pavel Mozgunov
University of Cambridge
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Christina Yap
The Institute of Cancer Research
Committee members
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Aimee Jackson
University of Birmingham
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Emily Alger
The Institute of Cancer Research
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Haiyan Zheng
University of Bath
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Simon Bond
Cambridge Clinical Trials Unit
Former leaders and members
- Simon Bond
Publications
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Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.pdf
BMJ 2023; 383 :e076387
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Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance.pdf
BMJ 2023; 383 :e076386
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Early phase clinical trials extension to guidelines for the content of statistical analysis plans.pdf
BMJ 2022; 376 :e068177
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How to design a dose-finding study using the Continual Reassessment Method
BMC Med Res Methodol 19, 18 (2019)
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Embracing model-based designs for dose-finding trials
Br J Cancer. 2017 Jul 25;117(3):332-339
Past events
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Practical Approaches to Dose Optimisation in Oncology Trials
11 December 2025
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Implementing novel designs in early phase dose-finding trials
20 September 2021
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CONCORDE: a phase I platform trial using the TiTE-CRM design
28 October 2020
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Flexible early-phase design for drug combination studies
30 September 2020
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Implementing a Bivariate Continual Reassessment Method in a Non-Oncology First In Human Trial
29 July 2020
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A dose-finding design for dual-agent trials with patient-specific continuous doses of one agent
24 June 2020
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NIHR Statistics Early Phase Trials Group Meeting 2019
28 February 2019
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Second Workshop of the NIHR Statistics Group’s Early Phase Trials Research Section
16 February 2018
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3+3 Consensus meeting
3 December 2014