Specific Challenge:While there is an emerging consensus among stakeholders that patients’ values and perspectives are important to inform decision-making processes during the development of medicines as well as during the approval and post-approval phases, it is not clear when patient perspective elicitation on benefits and risks of medicinal products is most valuable, and how this can best be performed.
Scope:To establish recommendations with the view of supporting the development of guidance for industry, regulators and health technology assessment (HTA) bodies on how and when in the product life-cycle to consider patient perspectives on benefits and risks of medicinal products to inform the decision-making process by regulators and HTA bodies.
Expected Impact:Consensus between patients, physicians, regulators, HTA bodies, academia and industry stakeholders on an approach, including a set of methodologies suitable for patient involvement, acceptable to regulators and HTA bodies for inclusion of patient preferences to inform benefit-risk decision-making throughout the product life-cycle:
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