3+3 Consensus meeting

Category: Early phase clinical trials

Location: Cambridge Trials Unit | Date: 3 December 2014

The Early Phase Clinical Trials Research Section of the NIHR Statistics Group, led by Dr Simon Bond at Cambridge Clinical Trial Unit, aim to address the ongoing use of the 3+3 design to find maximum tolerated doses in early phase studies. Within the statistical community it has been established for decades that this design has many flaws and many better alternatives exists. However, it is still routinely used in many academic-led studies.

This initial meeting invited statisticians from across the UK clinical trials and research methodology community. The meeting consisted of talks and discussion in the morning followed by an afternoon of workshops.  The aim of the meeting was to reach an agreement on how to solve this problem and establish a collaborative working party.

Meeting documents



Beyond the 3+3 design: how to find the optimal dose
Dr Adrian Mander, Cambridge Hub for Trials Methodology Research
& Dr Thomas Jaki, Lancaster University

Bridging the gap with the non-statistical community – what sort of information should we be communicating and discussing?
Dr Alun Bedding, Roche Pharmaceuticals

Introducing model based dose escalation in a pharmaceutical environment
James Matcham, AstraZeneca

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