In c4c, we are thrilled to share the recent article from the Innovative Medicines Initiative (IMI) on how to make clinical trials more kid-friendly. This article highlights the importance of involving children and young people in the design and development of clinical trials, and includes first-hand experience from Joana Claverol, a member of the c4c PPI cross-cutting team.
c4c is passionate about ensuring children and young people participate in all aspects of clinical trials. In some countries children and young people need to give assent to participate in a clinical trial, but in in all countries children and young people, depending on their maturity and understanding, are capable of being part of the assent process. As researchers and medical professionals, we need to ensure that the content and wording of assent processes and forms are tailored to match the age and level of understanding of each child. Through this, a child or young person can declare that they understand the purpose of the clinical trial, its associated benefits and risks, and that they agree to participate.
We believe we should not only ask for a child or young person’s assent to participate in a clinical trial, we should also engage children and young people in activities, such as advising on clinical trial design, reviewing protocols and assessing patient documentation. Therefore, c4c is actively involving children and young people in the development of its network, by offering all children, young people and families the opportunity to sign up to the c4c patient and public involvement database, including children and young people as experts to provide advice on study design and development, as well as, offering an education course to staff in National Hubs on involving children and young patients and families’ in designing clinical research.
You can read the article in full from the IMI here: https://www.imi.europa.eu/news-events/newsroom/how-can-we-make-clinical-trials-more-kid-friendly