Duration: 30 months, from March 2018 to August 2020

Status: running EPF-co-led project

Funding programme: PARADIGM has received funding from the Innovative Medicines Initiative (IMI) 2 Joint Undertaking (JU). This JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, as well as from private partners from the consortium.

Partners: 34 partners --- 4 European patients organisations, 2 competent authorities, 3 academic teams, 1 Non-profit organisation, 2 SMEs, 1 Hospital, 21 Industry partners, 3 associations, 17 bio-pharmaceutical companies, 1 contract research organisation

What is the project about?

PARADIGM stands for ‘Patients Active in Research and Dialogues for an Improved Generation of Medicines’. This project aims to participate in the co-creation of a sustainable  framework that enables systematic, meaningful and ethical 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 of the medicine’s development lifecycle:

  • Research priority setting,
  • Design of clinical trials,
  • Early dialogue with regulators and HTA bodies.

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.

Project’s objectives


  • Strengthen the understanding of stakeholders’ needs and expectations for engagement (including underrepresented and vulnerable populations);
  • Develop an inventive and workable sustainability roadmap to optimise patient engagement in key decision-making points across medicines’ R&D;
  • Ensure maximum synergies with other initiatives focusing on the patient’s voice in the life cycle of medicines, like Patient Focused Medicines Development (PFMD) or the European Patient Academy on Therapeutic Innovation (EUPATI);
  • 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.

Impact on patient community

Better health outcomes are linked to expanding the therapeutic arsenal with innovative but most importantly efficient medicines, that are truly relevant to the needs of the patient communities. Over the next decade, clearly, the patient engagement in medicines development will be a paramount topic.

Our vision at EPF is that patient engagement is systematic, efficient, ethical and sustainable when it lies on three main pillars:

  • Investing in education of the patient representatives,
  • Fostering increase capabilities of all stakeholders to operate this engagement,
  • Sustainability of the process.

When it comes to patient education, EPF has been leading what was the first of this kind public private partnership in patient training, EUPATI (or European Patient Academy on Therapeutic Innovation). EUPATI is a flagship project for EPF and 96 patients from all over Europe have successfully graduated the programme. But training alone is only a part of what is needed to truly engage patients in the development of medicines.

Over the last two years, EPF was active along side with some of our members to put on the agenda of the IMI the topic of patient engagement. This is how PARADIGM, standing for “Patients Active in Dialogue and Research for Improved Medicines” was born.

Overall, the PARADIGM consortium brings together a critical mass of expertise and commitment to contribute in creating a common framework.

We are passionate and will work hard to represent the patient community while building in the operations of the project consulting mechanisms to get as much relevant perspective as needed.

EPF is leading a collective effort, that will tremendous advance for our community.


The consortium, coordinated by EPF, comprises of 34 leading pan-European patient organisations, academic and not-for profit organisations as well as EFPIA member companies. It features excellence across disease areas in state-of-the art, high quality, objective education to patients about therapeutic innovation. It will foster collaboration between patient organisations, academic institutions, regulatory bodies, ethics committees and the industry.



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