A benefit-risk assessment is the pivotal moment during the evaluation of a new medical product by regulators. Such assessments also influence companies’ development strategies and future reimbursement decisions.
So how are these assessments made – given all of the uncertainties that surround benefits and risks? Perceptions can vary between various stakeholders during medicine development, and variations can continue after marketing approval.
Escher research has often focused on how to improve benefit-risk assessment in marketing authorisation procedures. Escher has studied and developed practical instruments for benefit-risk assessments that could provide a valuable step forward. These instruments can improve decision-making by structuring and integrating information; by making explicit evaluations of data, uncertainties and clinical judgments; and by giving (visual) feedback.
The following projects have addressed issues in this area:
- Decision Making in Drug Regulation: Making Transparent the Perception of Risk, Values and Preferences used in the Benefit–Risk Assessment
- Decision support for benefit-risk assessment with imprecise preference information
- Expert decision making in the European Regulatory Environment: How individual characteristics of medical assessors may influence regulatory decision-making
- Making better use of clinical trials: Computational decision support methods for evidence-based drug benefit-risk assessment
- Patient perspective in the benefit/risk evaluation of drugs
- Regulatory benefit – risk assessment; different perspectives