PARADIGM is a European, IMI-funded, 30 months project. PARADIGM’s mission is to provide a unique framework that enables structured, effective, meaningful, ethical, innovative, and sustainable patient engagement (PE) and demonstrates the ‘return on the engagement’ for all players.
The objective is to develop much needed processes and tools for three key decision-making points: research priority setting, design of clinical trials and early dialogue. Building on advances at international level, PARADIGM will integrate the needs, perspectives and expectations of all actors (including vulnerable populations) involved and will also produce a set of metrics to measure the impact of patient engagement.
- Needs and expectations
Strengthen the understanding of stakeholders’ needs and expectations for engagement (including underrepresented and vulnerable populations);
- Sustainability roadmap
Develop an inventive and workable sustainability roadmap to optimise patient engagement in key decision-making points across medicines’ R&D;
- Maximum synergies
Ensure maximum synergies with other initiatives focusing on the patient’s voice in the life cycle of medicines, like Patient Focussed Medicines Development (PFMD) or the European Patient Academy on Therapeutic Innovation (EUPATI).
- Agreed metrics
Develop agreed patient engagement metrics 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;
Find more information on the initiative's website - http://imi-paradigm.eu/
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 (prioritisation of research, early dialogue between regulators and HTA and design of clinical trials).
We define patient engagement as the effective and active collaboration of patients, patient advocates, patient representatives and/or carers in the processes and decisions within the medicine lifecycle, along with all other relevant stakeholders when appropriate. Meaningful patient engagement brings mutual benefit to the community of medicine developers (meaning all stakeholders involved from the patients, industry, regulators, HTA bodies to the payers), and requires inputs into decision-making, co-production and dissemination of knowledge.
Problems addressed by Initiative
PARADIGM will address the need to establish transparent and integrated standards that permit patient involvement during the medicines lifecycle, including associated templates, processes and services, pertaining to five specific issue groups: recognition of the validity and value of such engagement; metrics to demonstrate value; capability development; sustainability of the whole system, and rules of engagement.
Despite the increasing consensus that patient engagement is critical to fostering patient access to innovative therapeutic solutions, and delivering better health outcomes to patients, the emerging initiatives are inconsistent in methodology and fragmentation remains the norm. Patients continue to be a largely under-utilised resource in medicines development.
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