Benefit-risk is a methodology used to simultaneously evaluate multiple aspects of a treatment i.e. the effectiveness on the primary health outcome, safety and cost. By assessing the trade-off between these different aspects, it allows decisions to be made on the most overall beneficial treatment and therefore ensures this is utilised in practice. This methodology is already commonly used within the pharmaceutical regulatory setting and there is a need to transfer this to NIHR funded trials.

BRAINS is a methodological project which has been funded by MRC. The aim of the project to ascertain best practice when using this methodology and create guidance aimed at those designing trials that could implement this strategy. It is led by Professor Steven Julious with input from a range of methodologists from various backgrounds.

The project is made up of four workpackages:

1) A survey relating to current use of Benefit-Risk (Click here to complete the survey)

2) Rapid literature review of current recommended practice

3) An expert consensus workshop (see flyer in downloads)

4) Produce a guidance document for to aid the inclusion of benefit-risk methodologies within publicly-funded clinical trials.

Project Team:

Name Role Organisation
Professor Steven Julious Principle Investigator University of Sheffield
Nikki Totton Executive Group University of Sheffield 
Katie Biggs  Rapid Review Lead University of Sheffield
Professor Dyfrig Hughes  Executive Group Bangor University
Associate Professor Jonathan Cook Executive Group University of Oxford 
Dr Lizzie Coates Co-Applicant  University of Sheffield 
Dr Andrew Cook Co-Applicant  University of Southampton
Dr Simon Day Co-Applicant Clinical Trials Consulting & Training Limited
Professor Catherine Hewitt Co-Applicant University of York
Professor Byron Jones Co-Applicant Novartis Pharma AG
Dr Yvonne Lis  Co-Applicant Carter Lis Associates Limited