Report
Teaser, summary, work performed and final results
Periodic Reporting for period 1 - 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.)
Teaser
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...
Summary
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.
Work performed
The activities of PARADIGM during this first year focused on important ground work to deliver the most impactful outcomes and reach its overall mission. Much emphasis was placed in gathering the perspectives of all stakeholders involved in medicines development (WP1), through an online survey that was co-constructed by several different workstreams to ensuring that their needs (as per a WP perspective) were covered. To capture the perspectives of stakeholders’ groups that are usually hard to reach through online surveys, several focus group consultations were organized. The results of these activities were the basis for three Delphi exercises covering the three decision points addressed by PARADIGM.
In parallel, teams working on developing the monitoring and evaluation framework (WP3) and the assessment of practices and processes (WP2) jointed force to collect cases to start developing the framework and the tool needed to perform a gap analysis. Both outputs were iteratively constructed during the 1st year of the project.
Those activities are not stand-alone as they are fundamental in framing work aimed to developing the practices, guidance documents, and processes that are currently absent and much needed in the patient engagement environment (WP2).
As none of the work described above would matter if the ecosystem of patient engagement is not sustainable, our consortium also focused on developing a sustainable roadmap aiming to address several dimensions of sustainability, the resources, the culture and the processes. The approach taken was to first assess and analyse what are the key elements that make several initiatives -outside of the area of patient engagement- sustainable. Afterwards, the learnings were transferred into the topic at stake in PARADIGM. This approach was instrumental broadening the perspective to then refocus, and this has proven to be very informative and led to rich discussions on crucial elements that the roadmap should address to make the patient engagement ecosystem sustainable.
It is clear that PARADIGM does not operate in a vacuum, and that there is a strong willingness from many actors to make patient engagement a greater reality. Due to its focus, nature and lifespan, PARADIGM cannot afford to duplicate the work of others and needs to trigger as many operational collaborations as possible. This is not about collaborating for the sake of it, it represents a genuine interest to engage within a coalition of the willing. It was with this in mind that the PARADIGM International Liaison Group (PILG) was devised, created, and rolled out. In short, the PILG is an exchange and, when appropriate, a co-creation hub to connect PARADIGM with like-minded initiatives. These include key Innovative Medicine Initiatives and other international efforts focused on the co-development and implementation of patient engagement practices in medicines development. The PILG enables synergies – through the identification of existing good practices – aligned with PARADIGM’s scope. It helps to reduce fragmentation and duplication while ensuring that PARADIGM outputs are aligned with the mission and vision of the international patient engagement community. This will enhance their uptake and future implementation. Where appropriate, the PILG also provides external guidance on the relevance of PARADIGM strategic objectives and deliverables. The PILG, combined with a comprehensive communication strategy, with communication materials and channels produced very early in the project, the PARADIGM consortium is on right track to ensure acceptance, uptake and buy-in of the main outcomes that will be produced during the 2nd reporting period.
Final results
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.
Website & more info
More info: https://imi-paradigm.eu/.