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

Project Information

Project-COMFORT

Grant agreement ID: 101163781

DOI

10.3030/101163781

EC signature date 16 December 2024

Start date 1 November 2024

End date 30 April 2028

Funded under

• Health

Total cost

€ 6 676 003,94

EU contribution

€ 3 038 705,00

Coordinated by

ARISTOTELIO PANEPISTIMIO THESSALONIKIS
Greece

Periodic Reporting for period 1 - Project-COMFORT (Patient-Centric blOod saMpling FOr impRoved healThcare (Project-COMFORT))

Reporting period: 2024-11-01 to 2025-10-31

Summary of the context and overall objectives of the project

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 patient-centric microsampling 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 patient-centric microsampling across Europe as a proven and reliable alternative to venipuncture
2) Harmonised and clear regulatory and Health Technology Assessment (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 patient-centric microsampling into decentralised trials and care pathways
4) Stakeholder engagement and patient involvement models and research on preferences and acceptability for patient-centric microsampling
5) Foundation for future: Enable access to the developed patient-centric microsampling scientific findings, tools and assessment measures for rapid uptake and integration of patient-centric microsampling 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.

More information from the project website: https://ihi-project-comfort.com

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The first year of Project-COMFORT has established a strong and coherent foundation for one of the most ambitious initiatives in patient-centric diagnostics in Europe. Bringing together a consortium of 54 organisations, this public-private-partnership aims to co-create and validate the infrastructure and evidence required to position Patient Centric micro-Sampling (PCmS) as a credible, accepted and scalable alternative to venous blood collection across routine care and clinical research.
During its first year, the consortium focused on establishing the governance, operational structures and scientific foundations needed to execute a complex, multi-country programme and a multi-site umbrella study. The year also included accelerated activities resulting from project approval conditions, including preparation for an independent interim protocol review and the establishment of ethics oversight. Despite timing challenges, the consortium demonstrated strong commitment, adaptability and collaboration.
Key achievements in Year 1 include:
• Establishment of a coordinated, functioning consortium with clear roles, governance and cross-work package collaboration models.
• Co-creation and advanced refinement of the umbrella clinical protocol for 7 sites across 5 European countries and with documentation.
• Early regulatory and ethics engagement to align study classification and requirements across multiple national authorities.
• Conducting a broad literature scoping review of PCmS and completing a comprehensive report capturing study designs and perspectives of patients, caregivers, healthcare professionals, regulators, and industry.
• Launch of a multilingual stakeholder survey co-developed with patient and partner input.
• Review and selection of device-assay pairs for the clinical protocol together with a ‘deep dive’ master list of devices, diagnostics, home equipment and relevant regulatory guidance (Decision Point 1).
• Extensive audit and development of logistics- including cross border shipment requirement model and master Standardised Operational Procedures for traceability and high-quality control (Decision Point 2).
• Framework designed to assess training requirements around knowledge, skills, and competency needs across different user groups for safety and consistency.
• Development of a phased approach to data management to effectively govern multi-site patient, clinical study and logistic data, alongside other research outputs and PCmS documentations.
Collectively, these achievements represent significant progress toward the project’s core objectives to develop a Gold-Standard European PCmS infrastructure, support regulatory clarity and scientific evidence generation, and establish a sustainable knowledge ecosystem for adoption and scale-up.
While several deliverables experienced short delays, these reflected the scale, novelty and cross-sector coordination effort required, rather than lack of readiness or execution. Importantly, all delayed tasks are in progress and expected to be completed in the coming period. The consortium’s transparent governance, proactive mitigation and adaptive collaboration approach ensured momentum was maintained throughout Year 1.
With solid foundations now in place, Year 2 will shift towards accelerating execution, evidence generation and early testing across participating sites. The consortium remains strongly aligned to the project’s purpose: to reduce burden and expand access by enabling patients—regardless of geography, mobility or care setting—to provide high-quality blood samples easily and reliably, improving both care delivery and clinical research inclusion.
Project-COMFORT enters its second year with clarity, confidence and shared commitment to delivering meaningful, measurable and lasting impact for patients and healthcare systems across Europe.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

This is the first year report, no results available at this time.