The Vall d'Hebron Research Institute (VHIR) has launched the BRIDGE (Breaking Barriers with Remote Integration for Global Pediatric Trials) project to drive the transformation of clinical trials in paediatrics. Through the creation of new research areas, the use of innovative digital tools and a collaborative model between centres, the initiative aims to ensure that any paediatric patient has access to safe and effective therapies, regardless of their place of residence or socioeconomic situation. This initiative has recently received funding from the Instituto de Salud Carlos III and is co-funded by the European Union - NextGenerationEU.

Although clinical trials are very common in the adult population, promoting these studies in the paediatric population is essential to obtain data demonstrating that treatments are also safe and effective, especially in exclusively paediatric diseases or rare diseases. Even for diseases that occur in adults and children, it is important to keep in mind that the populations are different and the lack of toxicity or dosing data may lead to a higher risk of side effects or lack of efficacy in younger children.

"The fact that the paediatric population is smaller compared to the adult population, and the diseases they suffer from are less common, makes it more difficult to conduct clinical trials. Often, the complexity of paediatric diseases and the geographical dispersion of the paediatric population make it difficult to offer clinical trials with state-of-the-art therapeutic approaches to this population", explains Dr. Xavier Cañas, director of Commercial and Contract Clinical Research at VHIR.

This is especially notable in children with rare diseases: it is estimated that approximately 342,000 children have a rare disease in Spain, of which only 0.15% participate in a clinical trial. "Trials are an opportunity to access innovative therapies that are not yet available. In addition, participation in research is essential to promote the development of effective and safe treatments", says Dr. Cañas.

New challenges to promote children's research

The BRIDGE project, led by Vall d'Hebron, introduces a new approach combining digital and face-to-face methods to boost clinical trials in paediatrics. It focuses on three key areas: increasing the capacity to conduct studies, improving interoperability and cooperation with other centres, and promoting accessibility and inclusiveness to reach more patients.

To increase the capacity for clinical trials, the project proposes the evolution of the current Clinical Research Area of VHIR. Thus, a specific unit will be created to carry out paediatric clinical trials, with environments adapted for children, and a pharmacy unit exclusively for these trials and independent of the care circuit. In this way, it is expected that study conditions will be improved to enable more and more complex trials to be conducted.

The project team will also create a clinical trial data management centre, with the aim of integrating clinical data obtained from different sources or different centres, always guaranteeing data privacy. This system will facilitate collaboration with other health centres and the pharmaceutical industry.

Finally, a virtual platform for clinical trials will be implemented, with telemedicine services. An artificial intelligence-based system will be developed to collect day-to-day patient data and facilitate the continuous monitoring of information needed for trials without the need for patients to travel to the hospital as frequently. It will also include a communication platform between healthcare professionals and researchers and patients. This is aimed at breaking down the barriers that currently limit access to clinical trials for patients who live further away from the hospital or who have difficulty travelling.

"With this project, which will run until 2027, we want to establish a new paradigm for clinical trials through digital transformation and the empowerment of patients, regardless of their place of residence or socioeconomic status, increasing the opportunities to receive innovative treatments", says Dr. Cañas.

A leading Campus in clinical trials

Vall d'Hebron has consolidated its position as a benchmark in clinical research at national and international level, with intense activity in the development of clinical trials that contribute to the improvement of treatments and quality of life of patients. In 2023, more than 2,100 clinical studies were carried out, of which more than 200 were paediatric trials, with the participation of more than 580 paediatric patients.

In addition, Vall d'Hebron is part of 20 European Reference Networks (ERNs), 43 Reference Centres, Services and Units (CSURs) and 12 Networks of Clinical Expertise Units (XUECs), which allows it to coordinate clinical trials with a broad vision with patients from all over Europe and other continents. This global and collaborative approach places the Campus in a privileged position within the international research network.

A Hub to boost paediatric research

Vall d'Hebron is firmly committed to research in child and adolescent health, with the aim of developing more effective treatments adapted to the needs of these patients. In this line, the Paediatric Research Hub of VHIR acts as an engine to facilitate collaboration and group efforts among the teams working in this field. Currently, 30 research groups are actively contributing, five of which are exclusively specialised in paediatrics.

The BRIDGE project follows this strategy and contributes to making paediatric clinical trials more efficient and inclusive through digitisation, cooperation between centres and improved accessibility. "This initiative reinforces our commitment to more innovative and inclusive research, with the aim that more children can access advanced treatments", explains Dr. Pere Soler, head of Section of the Pediatric Infectious Pathology and Immunodeficiencies Unit at the Vall d'Hebron University Hospital and head of the Pediatric Infection and Immunity Research Group at the VHIR and head of the Hub.

This study has been funded by the Instituto de Salud Carlos III through project UICM24/00003 and co-financed by the European Union - NextGenerationEU with funds from the Recovery, Transformation and Resilience Plan.