Over the last years, a Europe-wide trend towards a patient-focused approach and the involvement of patients is developing and is influencing the decision-making process related to the clinical research.
Patients involvement in paediatric clinical trials is recognized as an important added value at European and international level and an essential contribution to paediatric clinical research.
To foster patients’ empowerment, advocacy groups including young patients and healthy youngers, named YPAG (Young Persons Advisory Group), have been established from New Zealand to France, from Great Britain to the United States, with the aim to provide new perspectives and attitudes in the designing and conduction of paediatric clinical trials. Currently, 19 YPAGs exist across the world and work together within the iCAN (International Children’s Advisory Network) consortium to provide a voice for children and families in health, medicine, research, and innovation with a global impact.
At European level, eYPAGnet, the European YPAG’s network (member of Enpr-EMA) has been established and is coordinated by the Hospital Sant Joan de Déu (Barcelona) with the mission to improve the capacity of collaboration with the different actors who participate in the research and development process of innovative drugs.
The goals of eYPAGnet are to:
- Improve the capacity of collaboration with the different actors, who participate in the research and development process of innovative drugs
- Gather a variety of experience related with different pathologies
- Promote the planning and development of clinical research initiatives for children, on a European level
- Consolidate the curriculum of capacity-building and empowerment training programs to the young patients
- Promote and lead the creation of new chapters
- Empower the selection of professional careers in the scope of science, among the youth.
YPAGs aim to help the professionals involved in the clinical trials to overcome some though issues of the clinical research. For example, they could help to open and complete on time the trials, or could improve the recruitment of patients to agreed target and the retention of patients to completion.
In general, through the YPAGs, the clinicians involved in the trials could meet the needs of the patients, designing the study according to their necessities.
In this context, Consorzio per Valutazioni Biologiche e Farmacologiche (CVBF) in collaboration with the TEDDY Network and the paediatric University Hospital Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari – Ospedale Pediatrico “Giovanni XXIII” has recently created the first Italian Young Persons Advisory Group (YPAG) in Bari (named KIDS Bari).
The event, took place on 7th June in Bari at the Paediatric Hospital “Giovanni XXIII” and was the occasion to present YPAG initiatives and to launch the group KIDS Bari at the Paediatric Hospital “Giovanni XXIII”.
The main objective of KIDS Bari will be to help researchers develop research questions, design trials, improve communication with the target population, and brainstorm methods for dissemination of findings. In other word this means “Advocacy”: paediatric patients take care of themselves, stating their right to be informed through the most adequate language and means, and providing voice to their opinions.
A new group in Tirana, named KIDS ALBANIA, will be launched by Consorzio per Valutazioni Biologiche e Farmacologiche – Dege e shoqerise se (CVBF Albanian Branch Office) in September in collaboration with TEDDY and the University Hospital Center “Mother Teresa”, service of paediatrics (Tirana).