The decision-making process and benefit-risk assessment
Decision Making in Drug Regulation: Making Transparent the Perception of Risk, Values and Preferences used in the Benefit–Risk Assessment
This project develops a way to include patient preferences in benefit-risk assessment procedures for medicines. Currently, regulatory agencies are developing new quantitative frameworks for the assessment of the benefits and risks of potential medicines. However, as of yet there is no place for patient preferences in this framework. While many regulatory stakeholders agree that it is important to include patient preferences, patients often have trouble expressing their preferences in numerical or quantifiable terms.
A research method called ‘MACBETH’1 solves this problem, because it translates patients’ qualitative expressions of preference into quantitative data. This research project aims to achieve two results: first, it assesses the feasibility of collecting patient preferences on the benefits and risks of medicines – using both the MACBETH and other methods; and second, it constructs a measure of patients’ benefit-risk trade-offs between various health outcomes of potential medicines.
If successful, the results of this study will provide a qualitative methodology that is easy for patients to understand; can be quickly deployed to gather additional data from a diverse population of patients; and can be easily included in clinical trials – pre- or post-approval – and collected as a part of the Patient Reported Outcomes set of questions.
1 MACBETH: Measuring Attractiveness by a Categorical Based Evaluation Technique