EMA looks at ways to boost patients\' contribution to pharma development
Accepts that there are challenges in incorporating patients’ views in decision-making
Methods of improving the way that pharma companies and regulators include patients in the development of medicines have been debated at a European Medicines Agency (EMA) workshop. The agency has been promoting the involvement of patients in such work, from early innovation to treatment monitoring, but accepts that there are challenges in incorporating patients’ views in decision-making.
'Because the views of patients on the benefit and risk of a medicine can differ from those of other stakeholders, and may also vary among patients and at different disease stages, this process often requires innovative approaches and methodologies,' EMA said.
Experts at the workshop debated how to identify where 'quantitative versus qualitative input' is needed from patients; and developing tools for eliciting preferences, while assessing benefit and risk.
They also discussed how to identify and manage differences of opinion among patients, and between patients and pharma professionals. And they debated how to train patients to maximise their involvement.