Developing a model to include patients in benefit-risk assessment
Research type
Research Study
Full title
Developing and validating a semi-quantitative model for the benefit-risk assessment of medicines, incorporating patient views as key criteria in decision making
IRAS ID
143944
Contact name
Paul Cross
Contact email
Sponsor organisation
Cardiff University
Research summary
Before a new medicine is approved to be sold, data must be available to demonstrate the safety and effect of the drug. A detailed assessment is completed using all available clinical trial data; to ensure the benefits of the product are carefully balanced against the risks. Benefit-risk assessment is a pivotal stage of the drug approval process and is an important task for regulatory agencies and pharmaceutical companies. There are a number of different models used for benefit risk analysis. For example, 'Multi-Criteria Decision Analysis' is one type of model which involves developing a list of relevant benefit and risk criteria that can then be used for determining a benefit risk profile. These criteria are organised depending on their importance in the overall decision (called ‘weighting’). Each criterion can be scored, weighted and then a calculation can be undertaken using computer software.
Involving patients in the research process is not a new concept; however involving patients in the area of benefit risk analysis is new. It has been identified by several parties that patients have a vital role to play as they can offer a different and unique point of view. This is because patients, who are taking medications for their various conditions, may view benefits and risks very differently when compared against the views of pharmaceutical companies or regulatory assessors. This project will investigate how the opinions of patients, obtained via patient focus groups, can be incorporated into a benefit risk assessment framework and a method will be developed and validated to do this.
REC name
London - Surrey Research Ethics Committee
REC reference
14/LO/1589
Date of REC Opinion
30 Sep 2014
REC opinion
Further Information Favourable Opinion