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25 November 2020

The PARADIGM project – a game-changer for patient engagement in R&D

Key players in the healthcare industry are constantly striving to strengthen patient involvement in the development of new medicines. The PARADIGM research project brought together 34 organisations to find ways of moving towards this goal.

“PARADIGM aimed to improve patients’ quality of life by integrating their insights into R&D activities.”

Martina Yuri,

Head of Development, Grünenthal

Patients can and should be more closely involved in the development of medicines. This approach is gaining recognition from regulatory bodies, Health Technology Assessment (HTA) authorities, healthcare professionals, companies and representatives from across the healthcare sector. However, many stakeholders still have questions about how to put this idea into practice. Who should be involved? What should they do? And when should they do it?

The PARADIGM project was initiated in 2018 as part of the Innovative Medicines Initiative (IMI), a partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA). PARADIGM stands for Patients Active in Research And Dialogues for an Improved Generation of Medicines. The project brought together participants from 34 organisations, including representatives from patient organisations, regulatory bodies, academia, non-governmental organisations, trade associations and pharmaceutical companies – like Grünenthal. Together, we aimed to develop tools that could promote sustainable and meaningful patient engagement across the lifecycle of medicines. After 30 months of intense work, the PARADIGM project ended with a final Open Forum session on November 23.

What did the project focus on?

In a spirit of open collaboration, all participants discussed and defined how patients should be involved in shaping the development of new therapeutic options. They focused on three key aspects:

  • Research and priority setting: Gathering valuable insights from patients to help set effective research priorities by identifying unmet needs and defining the most relevant outcomes for a given indication.
  • Clinical trial design: Empowering patients to contribute to the design of clinical trials by defining meaningful endpoints and help to shape trial procedures to make them more patient-friendly – which can improve recruitment and retention of patients.
  • Early dialogue with regulators and HTA bodies: Encouraging patients to support improved access to health innovations by providing input about their preferences, values and priorities for the treatment of their disease.

What are the outcomes of PARADIGM?

PARADIGM provided a framework for well-structured, effective, meaningful and ethical patient engagement, and demonstrated the return on engagement for all stakeholders. Moving forward, a Patient Engagement Toolbox will support organisations in conducting successful patient engagement activities. It brings together all of PARADIGM’s recommendations, tools and relevant background information. For example, it helps to find the right match for a patient engagement activity, and displays the required capabilities for patient engagement. It is the result of a substantial co-creation effort involving extensive research, surveys, focus groups, case studies and workshops.

Moving forward, the tools and resources generated during this project will be hosted by the partners EUPATI and PFMD to ensure their long-term use and sustainability, and to provide all stakeholders with easy access to this material.

For more information, please visit the PARADIGM website.

 

“PARADIGM produced remarkable and at the same time very practical tools that will help us to embed patient engagement into our R&D processes – and throughout the entire lifecycle of our products in a way that is directly focused on patients’ needs.”

Gudula Petersen,

Governmental Affairs & Patient Engagement Expert, Grünenthal