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:

Owen, R. Webinar on individualised benefit-risk Career Young Statistician Session, PSI conference in June 2020 (Access to PSI Members only).

Totton, N. & Julious, S. Benefit-Risk Assessment Breakout Session NIHR Statistics Conference 2019.

Totton, N., Julious, S., Hughes, D. & Cook, J. MRC-NIHR Methodology Guideline Development on Utilising Benefit-Risk Assessments within Clinical Trials ICTMC Conference 2019 (PS1C-01).

Hughes, D. Waddingham, E. et al. Recommendations for benefit-risk assessment methodologies and visual representation. Pharmacoepidemiology and Drug Safety 2016.

Nixon, R., Dierig, C., Mt-Isa, S., Stockert, I., Tong, T., Kuhls, S., Hodgson, G., Pears, J., Waddingham, E. et al. A case study using the PrOACT‐URL and BRAT frameworks for structured benefit risk assessment. Biometrical Journal 2015.

Waddingham, E. et al. A Bayesian approach to probabilistic sensitivity analysis in structured benefit‐risk assessment. Biometrical Journal 2015.

Hallgreen, C., Waddingham, E. et al. Benefit–risk assessment in a post‐market setting: a case study integrating real‐life experience into benefit–risk methodology. Pharmacoepidemiology and Drug Safety 2014.

Other Useful Links:

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

Join the NIHR Statistics Group - Subscribe for the latest news, updates and event information.