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The decision-making process and benefit-risk assessment

Escher looks at how benefit-risk assessments for medicines are made in regulatory agencies and HTA bodies, and studies how these assessments affect development strategies in companies. In addition Escher has developed tools for structured benefit-risk assessment.

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:

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