There is growing recognition that patients can and should be more involved in the medicines development process. However, many stakeholders still have questions on how to put this principle into practice – who should be involved, how, and when? The PARADIGM project aims to provide a framework for structured, effective, meaningful and ethical patient engagement and demonstrate the ‘return on engagement’ for all stakeholders. Building on existing initiatives, the consortium will develop a comprehensive set of tools and practices to support the integration of patient perspectives into drug development and enhance trust among different stakeholders.

The project will focus on three decision-making points in the medicines development process: research and priority setting; clinical trial design; and early dialogues with regulators and health technology assessment (HTA) bodies. Ultimately, the team hopes that the project will help patient engagement to become a reality and standard practice, helping to improve research and deliver results that are focused on patients’ needs.