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3+3 Consensus meeting

Event information

Location: Cambridge Trials Unit

Date: 3 December 2014

Working group: Early phase clinical trials

The Early Phase Clinical Trials Working Group aims 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 exist. 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

Agenda.pdf

Talks

Beyond the 3+3 design: how to find the optimal dose.pdf
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?.pdf
Dr Alun Bedding, Roche Pharmaceuticals

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