Patient-Centric blOod saMpling FOr impRoved healThcare (Project-COMFORT) (Project-COMFORT)

Framework: Horizon Europe — Global Challenges and European Industrial Competitiveness
Programme: Health
Theme: Public-private partnerships
Destination: Innovative Health Initiative
Action type: Research and Innovation actions
Partnership: IHI (JU-JTI)
Countries involved: Greece,Sweden,Spain,Italy,Netherlands,United States,Germany,France,United Kingdom,Belgium,Switzerland,Ireland,Czechia
Call: Patient-centric blood sample collection to enable decentralised clinical trials and improve access to healthcare (HORIZON-JU-IHI-2023-04-two-stage, 2023)
Start date: 2024-11-01
End date: 2028-04-30
Duration (months): 42.0
Total project cost (EUR): 6676003.94
EU funding (EUR): 3038705.0
Participants: 57
Project status: SIGNED

Background Health systems face a time of unprecedented change, with spiraling costs, increasing cultural disparity in access to healthcare and research, and an infrastructure that is decades old. Today, telehealth is a realistic alternative making care and research more accessible and personalised with less burden to better support the most vulnerable and under-served in our society. The ability to test and monitor for illnesses using Patient Centric micro-Sampling (PCmS) is at the centre of this reform. Aim and main objectives This project is designed to build upon existing pilots and knowledge, then collaborate cross-sectorially to co-create and test the logistics, infrastructure and tools required to make PCmS a core healthcare tool and an acceptable alternative to venous blood-draw across Europe. This project aligns with many IHI’s objectives focusing on cross-sectorial collaboration, emphasizing patient and end-user- centric co-design of outputs, harmonised regulatory and data generation approaches enhancing the potential of digital innovations in healthcare, while aiming to reduce the environmental footprint during the project and in final outputs to ensure that the expected long-term impact is a reachable reality that will deliver significant benefit to the community and address unmet public health needs at scale. To achieve our objectives, we bring together a broad group of required expertise, know-how and end-users (i.e., public and patients) to form a public-private-partnership specifically equipped to tackle this challenge. This collaborative approach where the relevant stakeholders such as healthcare professionals, regulatory agencies and patients are involved and integrated to deliver solutions and innovation across healthcare systems and ensure the best chances for success and long-term positive impact from this project. Key deliverables include: 1) An optimized, tested and validated ‘Gold Standard’ infrastructure and workflow for PCmS across Europe as a proven and reliable alternative to venipuncture 2) Harmonised and clear regulatory and HTA pathways, standards and acceptability, measures and cost-benefit models across Europe 3) Documented evidence to draw a citable ‘line in the sand’ for future research to support decisions to integrate PCmS into decentralised trials and care pathways 4) Stakeholder engagement and patient involvement models and research on preferences and acceptability for PCmS 5) Foundation for future: Enable access to the developed PCmS scientific findings, tools and assessment measures for rapid uptake and integration of PCmS approaches into decentralised clinical studies and healthcare Expected impact: - Patient-centric microsampling becomes an accepted alternative to the current standard of care venipuncture and the data gathered can be leveraged in healthcare planning. - Lowered patient burden and lowered barrier to access in situations where blood samples need to be collected, whether as part of diagnosis, care plan, health monitoring etc. - A solution to leverage high amounts of data gathered from increased testing can be explored already in this project so that it can pave the way for future research that can improve health outcomes.

Keywords: patient centric blood microsampling,patient benefit,health access for vulnerable populations,reduced environment impact,telehealth,de centralised and hybrid trials,regulatory harmonisation