Caring for children through research
Pediatric trials allow to validate the safety and efficacy of treatments and proper dosing
Paediatricians have been fighting from the beginning against the false assumption that children are small adults and that it is posible to simply give them smaller doses of the same medicines that have been approved for the adult population.
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.
An innovative approach in the development of the Pediatric Clinical Research
At RECLIP we are also concerned with the participation and engagement of patients in the development of clinical trials. Our objective is to work with the sites members of RECLIP and the Young People Advisory Groups (YPAG) at a national level, in order to serve as a point of contact, coordination and meeting point, counting on the valuable collaboration of Hospital Sant Joan De Deu, one of our sites that is undoubtedly the most active in Patient & Public Involvement (PPI) activities.
Our network works to involve patients and patient representatives in clinical research activities, and as a participant in the c4c project, RECLIP joins efforts to promote awareness through patient organizations, in order to facilitate and support patient and family participation in research, both at national and European level.
Thanks to our partnership with conect4chidren, we work steadily on innovative approaches in the development of the Pediatric Clinical Research, as the involvement of patients, families/caregivers regarding clinical trials design. Some examples of activities in which patients will be involved include protocol and information addressed to the participants of the trials.
c4c has setup a database to gather information on patients, caregivers, patients organizations and/or YPAGs (Young Person’s advisory boards) of rare/pediatric diseases willing to act as experts providing advice when required.
c4c has built a repository or bank of educational materials that can be used to provide information to patients participating in clinical trials, as well as their families or YPAGs (Young People Advisory Groups). These materials allow to advance and progress in crucial aspects of involvement of paediatric patients in the development of medicines.
In this section, patients and their families will find materials that will help them understand what a clinical trial is, what happens in a clinical trial, what ethical and legal implications entail and what role patients’ (and their families) can play in the development of a clinical trial.
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.
Through the different courses offered, the participant will gain training and expertise into all relevant aspects of the organization, implementation and delivery of pediatric clinical trials.
The courses are exclusively reserved for the c4c Consortium. Kindly contact RECLIP if you wish to participate (email@example.com)