Driving paediatric research in Spain
The regulatory and operational challenge in paediatrics
Children process medicines differently due to the development of their organs and metabolism: they are not small adults, and giving lower doses is not enough. Paediatric clinical trials are the only way to validate safety, efficacy and proper dosing according to age.
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.
The advantages of belonging to RECLIP
Dr. Federico Martinón Torres, General Coordinator at RECLIP, talks about how the RECLIP network supports sponsors of clinical trials.
An innovative approach to the development of paediatric clinical research
At RECLIP we are also concerned about patient involvement in the development of clinical trials. Our goal is to work with RECLIP member centres and Young Persons' Advisory Groups (YPAGs) at national level, so that we can serve as a point of contact, coordination and meeting, with the valuable collaboration of the Hospital Sant Joan de Deu, undoubtedly one of our most active centres in patient involvement initiatives and PPI (Patient & Public Involvement) activities.
Our network works to involve patients and patient representatives in clinical research activities, and as a participating entity in the c4c project, RECLIP joins efforts to raise awareness through patient organisations, with the aim of facilitating and supporting patient and family involvement in research, both at national and European level.
Thanks to our collaboration with conect4children, we are constantly working on innovative approaches to the development of paediatric clinical research, seeking the involvement of patients and families/caregivers in the design of clinical trials. We are fully aware that the success of clinical research in paediatrics lies in having the opinion of patients and their families on such relevant aspects of the clinical trial as the design of the protocol itself and the review of the information addressed to participants in the clinical trial.
The European conect4children network has set up a database that collects information on patients, caregivers, patient organisations and/or YPAGs in paediatric rare diseases, willing to participate as experts by providing advice when necessary.
We offer specific training courses for the clinical research community in Spain
RECLIP develops and collaborate with different entities to offer specific training courses for the clinical research community across Spain. Specialized training materials and resources are fully available to investigators and teams developing their clinical research activity in pediatric population.
RECLIP members and stakeholders get access to a full catalogue of internal and external courses through the c4c Academy learning platform.
The c4c Academy is designed to provide educational tools and training materials specifically tailored to the needs of all the c4c beneficiaries involved in the conduct of pediatric clinical trials. Through the educational platform, c4c beneficiaries will gain greater insight and expertise into all relevant aspects of the organization, implementation and delivery of pediatric clinical trials, including those focused on regulatory approval of new pediatric drugs.
The courses are exclusively reserved for the c4c Consortium. Kindly contact RECLIP if you wish to participate (contact@reclip.org)