The overall goal of patient engagement throughout the research and development of medicines is to develop safer, more effective therapeutic solutions for patients closely related to their needs, and to deliver them faster and more efficiently - through both the existing and evolving decision-making systems and development plans. The overarching mission of PARADIGM is to develop a framework that allows structured, meaningful, sustainable and ethical patient engagement throughout three key decision-making points of the development of medicinal products. To achieve this mission, PARADIGM was set up with five specific goals to:
• Strengthen the understanding of stakeholders’ needs and expectations for engagement and establishing criteria for meaningful engagement towards patient-oriented healthcare;
• Drawing on the above, reflecting the theory of patient engagement, and on participatory approaches, develop agreed metrics with validated tools to increase evidence demonstrating the impact of patient engagement practices;
• Strengthen systems-readiness towards patient engagement across the diverse range of stakeholders that develop, regulate and assess medicines; through this,
• Ensure the dissemination and adoption of practices and concrete and workable solutions and recommendations on capabilities, processes and rules of engagement;
• Ensure maximum synergies with other initiatives focusing on the patient’s voice in the life cycle of medicines, for example Patient Focused Medicines Development (PFMD) a global social venture, the European Patient Academy on Therapeutic Innovation (EUPATI) which is driving training and education for patients in Europe, and the patient community at large; and create structured opportunities to liaise with all relevant international players in the field to share, co-create, stimulate buy-in and acceptance and foster cultural change;
• Develop an inventive and workable sustainability roadmap to optimise patient engagement in key decision-making points across medicines’ R&D, demonstrating the inherent link between patient education, patient engagement and truly valuable innovation, and ensure long-term use and iteration of the resources developed during the project with sustainability models responding to the needs of each stakeholder group.
