Patient involvement in scientific committees in the assessment of benefits and risks of medicinal products

This project assesses how and whether patient participation in benefit-risk assessment can make a valuable contribution to medicine development. Patients are the primary reason for medicine development and are the stakeholders most directly affected by the choices made. Therefore, it is widely acknowledged that patients ought to be more involved in the development process. However, patients taking on roles as reviewers, co-researchers, or the driving force in medicine development does not seem suitable in, or beneficial to the medicine development process.

If patients cannot take on these roles, then how can they effectively and efficiently participate? This project takes up the question in the context of benefit-risk assessment. The project first establishes the value of patient participation in its assessment of benefits and risks within scientific committees, and also describes the type of patient participation that can make a valuable contribution to benefit-risk assessments. Since current ways of patient participation could easily become obstacles in medicine development and its limited extent may become a source of public distrust, this project helps medicine development and regulation become a process of cooperation and collaboration with patients.