Benefit – Risk
Benefit – Risk is a large methodological area which is commonly used within the regulatory industry to trade-off the benefits of a treatment with the risks, however this is not commonly transferred to NIHR trials.
This section aims to bring to focus the use of benefit-risk methods which could be implemented in NIHR projects. This will be achieved by bringing together useful resources and researchers in this area to share experiences and best practice.
There are resources available online about benefit-risk (see links below) but we hope for this group to have the specific focus on NIHR-funded studies and how to specifically support the use of benefit-risk methods in these.
Links from Working Group Members:
Totton, N. & Julious, S. Benefit-Risk Assessment Breakout Session NIHR Statistics Conference 2019.
Other Useful Links:
PROTECT Group
This website is a thorough overview of many different elements of benefit-risk assessment and many useful resources from their work. This is a good place to start to get a better understanding on benefit-risk in practice.
PSI Benefit-Risk Special Interest Group
This group have put together a blog which contains links to many useful articles and information as well as blog posts explaining specific aspects of benefit-risk assessment.
Food and Drug Administration (FDA) Guidance
European Medicines Agency (EMA) Guidance
Systematic Review completed by the PROTECT group
Mt-Isa, S. et al. Balancing benefit and risk of medicines: a systematic review and classification of available methodologies. Pharmacoepidemiology 2014.
Section leaders
Steven Julious
ScHARR, University of Sheffield
Nikki Totton
ScHARR, University of Sheffield
Committee members
Ruth Owen
London School of Hygiene and Tropical Medicine
Dr Ed Waddingham
Imperial College London
Evangelia Tzorovili
Queen Mary University of London
