Conect4children: A network for European clinical trials for children
On the last September 16th and 17th 2020 we took part in the 'c4c Workshop for Patients and Patient Organizations' addressing aspects related to the ethical implications and regulatory aspects of children and young people (CYP) involvement in clinical trials. We also had the opportunity to discuss the methodology behind the design and the carrying out of a clinical trial, as well as the structure and contents of research protocols.
Conect4children (c4c) is a European network which includes pharmaceutical industries, pediatric hospitals, experts, research institutes and patients organizations from 20 different Countries. It was created to encourage drug testing in the pediatric population, with a common and shared approach. The project aims to foster the creation of an integrated platform for conducting clinical trials in children and young adults across all conditions and phases of the drug development process.
LIRH Foundation follows this project with interest, in the hope that even young Huntington patients will benefit from it and with the aim of offering a contribution in this direction.
Patient and Public Involvement (PPI)
It is now clear that patients and their organizations should not be confined to a merely passive role, but should, instead, play an active and proactive role in the process of developing new drugs and the improvement of those already existing. The c4c project aims to extend this possibility also to pediatric and teen patients and their advocacy organizations, because their point of view matters and must therefore be taken into account.
Why involving patients - even minors patients - in research?
To be involved in any processes that affect our health directly is a right of each person, it is an essential part of the democratic process and, above all, it is useful to improve the quality of clinical trials. There are many ways and tools through which patients and their representatives can be actively involved: focus groups, questionnaires, interviews, participation in pharmaceutical industry advisory boards. Researchers, industries and the European regulatory authority (EMA) itself foresees the active participation of patients, adults and minors, and their organizations in different stages of the evaluation process of experimental drugs and in clinical trials.
Our Foundation strongly supports the participation of patients - both adult and pediatric - in Huntington's disease clinical trials.
For us, participating does not only mean to “take part” into research and be included into the study protocols. It also means that patients should not only be seen as 'sick' people, but also as 'experts' in their disease and - as such - able to express critical points of view and make useful contributions to improve the quality of scientific research.
To learn more about involving minor patients in clinical trials, watch the video.