The patient’s role in the benefit-risk assessment for the submission and review of new medicines
25-26 April 2012, Hampshire, UK
This workshop gained a perspective from various stakeholders in the development and review of new medicines on the opportunities and barriers to including patients’ perspectives in the submission and review of new medicines. The findings of this current workshop informed discussion at the CIRS annual Benefit-risk Workshop in June 2012 (Building the Benefit-Risk Toolbox), where the questions posed were when and how should patients be involved and what would facilitate their involvement with regard to the benefit-risk assessment of new medicines?
Workshop objectives
- Identify the issues and opportunities for patients, companies and regulators in including patients’ views in the benefit-risk assessment of medicines.
- Clarify how as well as when patients’ views should be incorporated into the benefit-risk assessment of medicines.
- Develop a proposal for discussion at the CIRS June Workshop to identify the methodologies to achieve a consensus on a scientifically acceptable approach for including patients’ perspectives in benefit-risk decisions.