Eliminating language barriers is key to ensuring that pediatric patients can access and participate in clinical trials beyond their country of origin

The study Cross-border access to clinical trials: participation of pediatric patients and language inclusion, led by researcher Begonya Nafria, head of the Patients Engagement in Research group at Institut de Recerca Sant Joan de Déu (IRSJD) and SJD Barcelona Children’s Hospital, highlights the importance of ensuring equitable access for children and young people to international clinical trials, especially in the field of rare diseases.

The research, published in Nature (Pediatric Research), analyzes the participation of pediatric patients in clinical trials with cross-border recruitment and identifies the key role that language barriers play in this process.

Language, a key factor for equity

The study reviews 21 clinical trials with international participation conducted at Sant Joan de Déu between 2011 and 2024. In total, data from 314 patients were analyzed, more than half of whom came from outside Spain, representing up to 44 different countries.

The results show that, despite the great linguistic diversity, international participation is feasible if adequate resources are available, such as translation services or specific support for patients and families.

However, the analysis also shows that many clinical trial protocols do not systematically incorporate aspects related to language criteria in the selection of participants.

A particularly relevant challenge in rare diseases

The research team highlights that this issue is especially critical in the case of pediatric rare diseases, where clinical trials are often the only therapeutic option available and require the participation of patients from several countries in order to achieve sufficient sample sizes.

In this context, limiting access for language-related reasons may constitute an unjustified barrier and reduce treatment opportunities for many children.

"In many pediatric rare diseases, participating in a clinical trial may be the only therapeutic option. Therefore, we cannot allow factors such as language to limit children's access to research, failing to respect the right not to be discriminated against because of one's mother tongue. We must move towards more flexible and inclusive models that place patient benefit at the center," concludes Begonya Nafria, head of the Patients Engagament in Research (PERA) research group at IRSJD and first author of the study.

Nafria led a second publication, Parents' Perspectives on Access to Pediatric Rare Disease Cross-Border Clinical Trials in Europe: Experiences of Language Inclusion and Preferences, published in Therapeutic Innovation & Regulatory Science, which complements this perspective by incorporating the preferences and experiences of families. The study highlights that language barriers not only affect the understanding of documents or clinical communication, but also the perception of equity and the real ability to participate in decision-making during the research process. Families identify language inclusion as an essential element for being able to access clinical trials under equal conditions.

Towards a more inclusive model

In conclusion, the research team concludes that the inclusion of international patients in pediatric clinical trials is feasible and that inclusion decisions should be based on potential clinical benefit, rather than on language or country of origin.

Furthermore, it points to the need to develop specific guidelines and regulatory frameworks that facilitate cross-border access and guarantee equity in pediatric clinical research.