Paediatric clinical research advances in Spain driven by collaboration between researchers, healthcare professionals and the pharmaceutical industry

Between 2020 and 2022, 446 clinical trials with children and adolescents were conducted in our country, almost half of them focused on rare diseases and 90.4% promoted by the industry.

Nearly 40 pharmaceutical companies and more than 30 researchers attended the 6th Monographic Conference on clinical research in paediatrics, organised by the Spanish Network of Paediatric Clinical Trials, Farmaindustria and the Hospital Sant Joan de Déu.

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Children and adolescents sometimes suffer from specific diseases that do not manifest themselves in the adult population. These pathologies require even greater research efforts to take these particularities into account and to find the best possible treatments. These are the premises under which researchers, health centres and pharmaceutical companies have been intensifying work in this area for years.

One of the initiatives in this field is the collaboration between Farmaindustria’s Spanish Technological Platform for Innovative Medicines, which this year has been joined by the Spanish Network of Paediatric Clinical Trials (RECLIP) and the Hospital Sant Joan de Déu (HSJD), which this Tuesday in Barcelona is holding the 6th Annual Conference on clinical research in paediatrics, with the participation of around 40 laboratories and more than 30 researchers.

The Director of Research, Innovation and Learning at Sant Joan de Déu Hospital, Joan Comella, expressed his satisfaction with the reception of the meeting: “We have brought together more than 70 professionals committed to research into rare paediatric diseases and their presence here is a testimony to the shared commitment to defining the needs and offering the most appropriate solutions for this group. This is an initiative that we at the Hospital Sant Joan de Déu have been firmly promoting through the creation of the Únicas network. The conference is not only a forum for dialogue and learning, but also a platform to promote research and innovation in new therapies in the world of paediatric diseases”.

RECLIP coordinator and head of the paediatrics department at the Hospital Clínico de Santiago, Federico Martinón Torres, also valued the collaboration in the first meeting that the network has joined: “Our objective, being a national organisation that works for and so that paediatric patients have access to the best medicines and treatments, is none other than to collaborate with clinical trial promoters so that each trial is developed in an agile manner and under the highest quality standards, supporting paediatric clinical research in Spain through the excellence of RECLIP’s member centres, the backbone of the network”.

The session was held under the title Facing challenges in paediatric research: building network solutions and served to update the situation of clinical trials with children and adolescents and to publicise initiatives linked to the participation of patients and their families.

“We believe that public-private collaboration is the best way for paediatric patients to gain more and earlier access to new medicines,” said Amelia Martín Uranga, director of Clinical and Translational Research at Farmaindustria. The Farmaindustria spokeswoman also highlights the importance of networked clinical trials in paediatrics, which “are essential to provide answers precisely to patients with complex minority diseases. That is why it is also important that there is an ecosystem of alliances that allows data to be shared in such a necessary area”.

Joana Claverol, Director of Clinical Research at the Fundació de Recerca Sant Joan de Déu, described the meeting as “a great opportunity to speed up research and carry out studies with the highest quality standards. Participation in this conference is a clear manifestation of our commitment to research in the field of rare diseases.

The figures support the efforts of recent years: between 2020 and 2022, 446 paediatric clinical trials were conducted in Spain, 15.1% of the total authorised by the Spanish Agency for Medicines and Health Products in the Spanish Clinical Trials Register (Reec).

Last year, with 173 trials and 18.7% of the total, paediatric research has further increased its presence in R&D in our country. The areas where most trials are conducted are oncology, nervous system diseases, haematology and viral pathologies.

46.6% of the research is for rare diseases and in recent years the number of early-stage trials has also increased, accounting for almost 40% of the total in 2020-2022. In the opinion of Martín Uranga, “this represents an opportunity for many children to benefit early from new treatments, which in some cases are the only therapeutic option”.

Industry involvement has also increased in recent years, with 90.4% of clinical trials in paediatrics being promoted in the 2020-2022 period. In total clinical research, companies drive 86%.

Important initiatives have also been recalled, such as the Document of recommendations to strengthen the participation of paediatric patients in the drug R&D process, a guide to ensure that these patients and their families participate and are considered in the process to improve their experience and achieve greater involvement in the research of new treatments.

The conference also includes a practical workshop on Lay summaries in paediatric studies, i.e. the executive summaries whose aim is to inform society as a whole of the results of a trial clearly and comprehensibly, following the recommendations at European level.