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27 March 2019 / Our Stories

Joining forces for patient-driven R&D

Partnering to empower patients to shape medical innovation through the PARADIGM initiative.

PARADIGM: Patient-focused collaboration

“Through open collaboration, we aim to transform patients’ involvement in developing new medicines”

PARADIGM stands for Patients Active in Research And Dialogues for an Improved Generation of Medicines. It’s part of the Innovative Medicines Initiative (IMI) and brings together 34 members, including representatives from patient organisations, regulatory and health technology assessment bodies, academia, non-governmental organisations, trade associations and pharmaceutical companies.

PARADIGM stands for Patients Active in Research And Dialogues for an Improved Generation of Medicines. It’s part of the Innovative Medicines Initiative (IMI) and brings together 34 members, including representatives from patient organisations, regulatory and health technology assessment bodies, academia, non-governmental organisations, trade associations and pharmaceutical companies. Through open collaboration, PARADIGM aims to transform the way patients are involved in shaping the development of new medicines – especially in setting research priorities and designing clinical trials, engaging in dialogue with regulators and Health Technology Assessment bodies. By pursuing this goal, we’re joining forces to put patients at the heart of pharmaceutical R&D activities and create standards, metrics and processes for patient engagement that are aligned with a wide range of health are stakeholders from all over the health care sector.

The collaboration began in March 2018 and will run for 30 months. It will give patients a stronger voice in shaping development activities and make sure new treatments meet their needs even more closely. In this way, PARADIGM is aiming to help improve patients’ quality of life by integrating specific insights about how symptoms affect their day-to-day activities. It follows a holistic approach: focusing on research methodologies that deliver value for patients, society and health care systems, while also seeking innovative solutions that reflect the clinical, emotional and practical implications of illnesses. Organisations from across the health care arena will benefit from the creation of a more structured framework for engaging patients in developing medicines – and will be empowered to design more effective R&D processes that are based on real-life insights from the people who matter most.

Within PARADIGM, we’re co-leading a workstream that aims to create a set of metrics for evaluating the impact of patient engagement in R&D. The project team has already reviewed existing literature about patient engagement and gathered more than 50 case studies. The work we’ve accomplished with our partners will be summarised in an article in the prominent journal Health Expectations in 2019. Moving forward, representatives from Grünenthal will continue actively collaborating with our fellow PARADIGM members. Together, we can strengthen the involvement of patients in R&D and engage in open dialogue as equal partners seeking the shared goal of developing more effective medicines for patients with unmet needs.

Grünenthal’s involvement in PARADIGM is just one element of our commitment to patient engagement, putting patients at the heart of everything we do. For example, we’re also working together with patient advocates to create pain assessments that are based on the specific needs of patients. This project is based on a survey involving more than 3,000 people who suffer from chronic pain. This demonstrated that the questions currently used to assess patients’ experiences of pain are not the most relevant from a patient point of view.

PARADIGM has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777450. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA, as well as from private partners from the consortium.

For further information:

PARADIGM Website: https://imi-paradigm.eu/
PARADIGM One-Pager: https://imi-paradigm.eu/wp-content/uploads/2018/10/PARADIGM_OnePager_v7.pdf
Blog about PARADIGM Work Package 3 “Development of metrics for monitoring and evaluation”: https://imi-paradigm.eu/determining-the-value-of-patient-engagement/


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


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