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Patients Active in Research and Dialogues for an Improved Generation of Medicines: Advancing meaningful patient engagement in the life cycle of medicines for better health outcomes.

Periodic Reporting for period 2 - PARADIGM (Patients Active in Research and Dialogues for an Improved Generation of Medicines: Advancing meaningful patient engagement in the life cycle of medicines for better health outcomes.)

Reporting period: 2019-03-01 to 2020-11-30

The overall goal of patient engagement throughout the research and development of medicines is to develop safer, more effective therapeutic solutions for patients closely related to their needs, and to deliver them faster and more efficiently - through both the existing and evolving decision-making systems and development plans. 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. To achieve this mission, PARADIGM was set up with five specific goals to:
• Strengthen the understanding of stakeholders’ needs and expectations for engagement and establishing criteria for meaningful engagement towards patient-oriented healthcare;
• Drawing on the above, reflecting the theory of patient engagement, and on participatory approaches, develop agreed metrics with validated tools 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; through this,
• Ensure the dissemination and adoption of practices and concrete and workable solutions and recommendations on capabilities, processes and rules of engagement;
• Ensure maximum synergies with other initiatives focusing on the patient’s voice in the life cycle of medicines, for example Patient Focused Medicines Development (PFMD) a global social venture, the European Patient Academy on Therapeutic Innovation (EUPATI) which is driving training and education for patients in Europe, and the patient community at large; and create structured opportunities to liaise with all relevant international players in the field to share, co-create, stimulate buy-in and acceptance and foster cultural change;
• Develop an inventive and workable sustainability roadmap to optimise patient engagement in key decision-making points across medicines’ R&D, demonstrating the inherent link between patient education, patient engagement and truly valuable innovation, and ensure long-term use and iteration of the resources developed during the project with sustainability models responding to the needs of each stakeholder group.
During the first half of the project, the consortium ran several activities, including a gap analysis to understand the missing elements and to meaningfully operationalise patient engagement in medicines development. The outcomes of this study was published in Health Expectations in 2021 'Understanding multi-stakeholder needs, preferences and expectations to define effective practices and processes of patient engagement in medicine development: A mixed-methods study'.
Flowing from the gap analysis, the consortium developed the Monitoring and Evaluation Framework with Metrics to help stakeholders assess value and embark on continuous improvement of their patient engagement activities, helping users to understand the impact of patient engagement and demonstrate better decision-making in medicines development. This work was published in the paper entitled 'Evaluation of patient engagement in medicine development: A multi‐stakeholder framework with metrics' in Health Expectations in 2021.
To strengthen the system-readiness, PARADIGM created the Patient Engagement Toolbox. This toolbox, accessible from both the EUPATI and PFMD IT systems, centralises all the PARADIGM co-created recommendations, tools and relevant background information. All of the materials are fully available, accessible with no paywall or registration wall and will enhance the capabilities of the different stakeholders to engage with each other. The toolbox can be found here: http://imi-paradigm.eu/petoolbox/
The work performed by PARADIGM was undertaken in a collaborative, coherent way. At the start of the project, the PARADIGM International Liaison Group (PILG) was established to strengthen the capacity of the consortium to capture the insights coming from other initiatives and therefore factor into the work of others in the development of the PARADIGM tools and recommendations. The 3 Patient Engagement Open Forum (PEOF) were co-organised with EUPATI and PFMD, members of the PARADIGM International Liaison Group. This initiative is continuing under the leadership of EUPATI, PFMD and the European Patients' Forum. More information can be found here: www.patientengagementopenforum.org
Patient engagement without sustainability will remain anecdotal. This is why the PARADIGM consortium dedicated an entire work package (WP6) to develop the patient engagement sustainability roadmap, setting up the strategic goals for the PE community to achieve meaningful and systematic PE through changes in the culture, processes and resources of stakeholder organisations. It brings in key PARADIGM outputs to work in a coordinated fashion with existing frameworks and mechanisms to achieve system-wide sustained PE. This work has been published in Therapeutic Innovation & Regulatory Science in 2021.
Patient engagement in medicines R&D is a hot topic but not yet engrained in the culture of the drug development process, even though there is a clear momentum to make patient engagement in medicines R&D the norm. PARADIGM is based on the premise that the ultimate impact of patient engagement will be a more robust response to true unmet medical needs- medicines developed faster, safer and more cost effectively that will support the healthcare systems to achieve better health outcomes. This is a win for all, a win for the society at large.
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