There are still many health conditions which only affect the paediatric population, this would be the case for 80% of rare diseases that lack approved therapeutic options. Clinical trials are essential for the development of new medicines. In the last years, in Europe the number of clinical trials for the paediatric population has increased. At the same time, the pharmaceutical industry became more aware on the importance of establishing solid collaborations with children, young persons, their families, and patients representatives to develop patient-focused clinical trials.
With this in mind, this guide has been put together by Farmaindustria, Spanish Paediatric Clinical Trials Network (RECLIP), the Spanish Paediatrics Association (AEP), the Sant Joan de Déu Hospital of Barcelona, and the Grupo KIDS Barcelona, with participation of representatives from several patient organisations, scientific societies, hospitals and pharmaceutical companies.
This guide provides relevant recommendations shared by several stakeholders in the pharmaceutical industry that ensure research and development (R&D) processes focused on paediatric patients and nurtured by close collaboration with them.
Eight different areas have been proposed in which patients participation as well as their contributions to the biomedical R&D processes can be integrated in an effective and valuable manner.
To know all about the integration of paediatric patients in clinical trials read the full document here.