A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings...

Area of Science:

• Regulatory Science
• Medicines Development
• Patient Engagement

Background:

• A workshop highlighted the need for greater patient involvement in medicines R&D and life cycle management.
• Key stakeholders (patients, academia, industry, regulators) discussed current challenges and perspectives on patient involvement.

Purpose of the Study:

• To explore the paradigm shift towards true patient impact in medicines development and regulatory science.
• To identify strategies for enhancing patient involvement throughout the medicines R&D process.

Main Methods:

• Workshop involving four key stakeholder groups: patients, academia, industry, and regulatory authorities.
• Breakout sessions to discuss the status and challenges of patient involvement.
• Analysis of stakeholder perspectives on patient engagement.

Main Results:

• Patient-reported outcomes are vital for determining clinical trial endpoints.
• Professionalization of patients is needed for greater influence, but industry must also adapt.
• Stronger, organized patient involvement is necessary, ideally supported by legal requirements.

Conclusions:

• A paradigm shift towards meaningful patient impact in medicines development requires structured and legally supported engagement.
• An independent platform for patient experience could facilitate better involvement.
• Institutions like CORS are well-positioned to host such platforms.