The Vall d’Hebron Research Institute (VHIR), the Jordi Gol Primary Care Research Institute (IDIAPJGol) and the primary care services of the Catalan Health Institute (Institut Català de la Salut, ICS) have begun the clinical phase of the European Project-COMFORT study. It is an international initiative whose objective is to transform the current blood collection models through innovative blood microsampling technologies.

The first participants have already been enrolled at the Roquetes Primary Care Centre (CAP), in Terres de l’Ebre, and Sant Martí de Provençals Primary Care Centre, in Barcelona, both belonging to the Catalan Health Institute (ICS), a step that consolidates the start of the healthcare activity linked to the project in Catalonia. In the case of Vall d'Hebron and IDIAPJGol, in Catalonia it is expected to reach at least one hundred participants within the overall study, which is being carried out in parallel in several European countries under the same harmonised clinical protocol.

The project stems from the need to reduce the burden associated with conventional blood draws, especially in populations that require frequent monitoring or that have difficulties accessing healthcare centres. Blood microsampling makes it possible to obtain small volumes of blood in a less invasive manner, with the possibility of implementing it in more flexible settings, even outside the hospital or the Primary Care Centre (CAP) under certain conditions.

This approach opens the door to new patient-centred clinical follow-up models, with the potential to improve adherence to medical monitoring, reduce unnecessary travel and optimise healthcare resources. At the same time, the project seeks to ensure that these new technologies maintain the analytical quality standards required for clinical decision-making.

Gemma López, family and community nurse and deputy director of the Sant Martí de Provençals Primary Care Centre (CAP), highlights the improvement in the patient experience: "This new, less invasive technique, together with patient education and training in the use of the device, can help improve their experience and the monitoring of their medical conditions."

The clinical phase that has now begun constitutes a key moment within Project-COMFORT, as it makes it possible to validate, under real-life conditions, the devices and procedures developed during the previous phases of the project. This stage includes the collection of samples in healthcare settings, in this case Primary Care Centres (CAPs), and the evaluation of their performance across different patient profiles and clinical contexts.

Dr Noèlia Carrasco Querol, coordinator of the study in the field of primary care and researcher at the Research Support Unit (USR) Terres de l’Ebre of IDIAPJGol, points out that the study may represent: "an advance in healthcare organisation if this technology is implemented in clinical practice for vulnerable groups such as children and older people, as well as for the population living in rural areas."

The research team is responsible for participant recruitment and the project's logistics. The team includes four nurses from the two Primary Care Centres (CAPs), who are responsible for performing the blood draws and managing the shipment of the samples to VHIR.

At Vall d'Hebron, the project is coordinated by Dr Roser Ferrer, Head of the Biochemistry Department at Vall d'Hebron University Hospital and Head of the Clinical Biochemistry, Drug Delivery and Therapy research group at VHIR. The project also includes the participation of Dr Simó Schwartz Jr, principal investigator of the Clinical Biochemistry, Drug Delivery and Therapy research group at VHIR, as principal investigator of the clinical study at the European level and responsible for coordinating the implementation across the different participating centres.

Dr Roser Ferrer highlights the importance of this milestone in the project's trajectory: "The start of patient enrolment represents a particularly significant moment because we move from theory and technical validation to real clinical practice. It is here that we can truly evaluate the potential impact of this technology on the daily lives of patients and healthcare professionals."

According to Dr Roser Ferrer, this phase will not only make it possible to verify the feasibility of blood microsampling but also to analyse aspects such as patient acceptance, the consistency of the results and its integration into healthcare workflows. "The challenge is not only technological but also organisational and clinical. We must see how these tools can fit into healthcare systems without losing rigour or diagnostic quality," she adds.

Regarding the scope of the project, Dr Simó Schwartz Jr also underlines its international dimension and the value of collaboration among centres: "We are talking about a coordinated effort at the European level involving a total of 51 institutions and companies. This allows us to compare results, share experiences and move forward in a much more robust way than if we were working independently."

European initiative

Project-COMFORT is a large-scale public-private partnership promoted by the Innovative Health Initiative Joint Undertaking (IHI JU), with the participation of 51 organisations from different sectors, including hospitals, universities, research centres, medical technology and pharmaceutical companies, and other entities from the biomedical sector.

Project-COMFORT is not only focused on the technological development of blood microsampling, but also on its future applicability within healthcare systems. This includes regulatory aspects, economic evaluation and public health impact, with the objective of facilitating its possible adoption if the clinical results support it. This milestone marks the entry into the project's real clinical phase after a period of development, technological validation and coordination among the different partners of the European consortium.

The project has total funding of €6.6 million and an expected duration of 42 months.

The project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under Grant Agreement No. 101163781. The Joint Undertaking receives support from the European Union's Horizon Europe research and innovation programme, together with contributions from COCIR, EFPIA, EuropaBio, MedTech Europe, Vaccines Europe, Jones Lang LaSalle SE and Miebach Consulting GmbH.

Likewise, the opinions and views expressed are solely those of the authors and do not necessarily reflect those of the European Union or the Innovative Health Initiative Joint Undertaking. Neither the European Union nor the Innovative Health Initiative Joint Undertaking can be held responsible for them.