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Aim

Pediatricians have fought from the beginning of their history against the false assumption that children are small adults and that when it comes to treating pediatric patients, we cannot treat them like tiny adults and simply give them smaller doses of the same medicines. Their developing and maturing organs and changing metabolism affect how they process drugs, and that must be taken into account when treating them.

 

The main and only way is through the conduction of pediatric clinical trials. Pediatric clinical trials can allow to validate the safety and efficacy of treatments and proper dosing in pediatric patient populations. Despite this clear idea, currently, only a small percentage of drugs and devices approved by the Food and Drug Administration (FDA) or the European Medicines Agency (EMA) are labeled for pediatric use. A fundamental culture change within and across organizations is required to change this picture.

 

Managing the logistical, legal, and cultural considerations is one of the main bottlenecks in pediatric clinical trials. Over the past 20 years, regulators all over the world, and particularly in the US and Europe, have rolled out a combination of incentives and regulatory requirements to promote more pediatric clinical trials. Despite this, understanding of the safety and ethical issues that govern this research is cumbersome even with the appropriate operational experience to manage pediatric trials.

 

RECLIP aims to address these gaps in Spain through strong super-specialized networking. RECLIP has been developed to cover the specific needs of pediatric clinical trials in Spain in a professionalized, multidisciplinary and organized stable fashion, gathering the most important pediatric clinical research units across the country, corresponding to the most important hospitals of Spain. RECLIP builds its strength and reliability on its cooperation with all key stakeholders inside and outside the network. RECLIP merges strong Spanish academic institutions experienced in collaborating with each other, and also with the industry. RECLIP is focused on the conduct of pediatric clinical drug or device trials in a variety of areas. The alliances established between the strong and experienced RECLIP centres reduce risk and uncertainty inherent to pediatric clinical trials by enabling collaborators to engage the best investigators and benefit from the shared expertise and best practices of all partners. Furthermore, the collective expertise of the organizations of RECLIP allows for less time spent on administrative tasks related to business processes and finding sites, and more time recruiting and managing patients within the trial.