When and how should the health research and development community involve patients in their work? IMI’s PARADIGM project is trying to find out.
There is now growing recognition that patients and their representatives can and should be involved in all stages of medicines development (R&D). But how do you do this in practice, and is it worth it? IMI’s PARADIGM project was set up in 2018 to create a framework for structured, effective, meaningful and ethical patient engagement, and to demonstrate the ‘return on engagement’ for all stakeholders.
The project focuses on patient involvement in three key points in the medicines R&D process: research and priority setting; clinical trial design; and early dialogues with regulators and health technology assessment (HTA) bodies. So what have they delivered so far?
With just months to go before the end of the project in August this year, the IMI Programme Office caught up with project coordinator Mathieu Boudes of the European Patients’ Forum (EPF).
‘PARADIGM is an atypical project – very short and most of the tangible achievements are due at the end of the project,’ explains Boudes. ‘We have robustly identified what is still very much needed by all actors involved in the development of medicines and that will make the most impact in terms of patient engagement. The consortium is currently developing a monitoring and evaluation framework for stakeholders who are doing patient engagement to help them measure the impact of their initiatives. It will be a game changer to bring patient engagement to the next level.’
The project is also developing specific tools; among others, these will build the capacity of all stakeholders who want to do more on patient engagement; support the identification of the right patients for the right activities at the right time; and help HTA bodies to engage with patients. In addition, a number of scientific publications are under review and should be published in the coming months.
Another highlight for the coming months is the next Patient Engagement Open Forum on 25-26 June. The previous edition of the event, held in September 2019, attracted over 250 people representing diverse stakeholders in medicines R&D. It was a great success, thanks in large part to the fact that the event was jointly organised by PARADIGM together with Patient Focused Medicines Development (PFMD) and EUPATI.
‘By the end of the project, we will also have developed a sustainability roadmap for patient engagement, a vision and a strategic plan for ensuring initiatives succeed now and over the longer term,’ says Boudes.
Once PARADIGM has finished, the tools and resources developed by the project will be hosted by partners who are already embedded in the patient engagement landscape; this will ensure they are easily accessible to all stakeholders.
‘For patient engagement in medicines R&D to be truly sustainable, the vision of PARADIGM needs to be implementable by all stakeholders, through tangible and actionable goals, activities and responsibilities,’ concludes Boudes. ‘In the long term, PARADIGM will be remembered as a driver for bringing patient engagement in medicines R&D to the next level, but also as a project that united various stakeholders and viewpoints that have merged and are now moving in the same direction.’
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