Insight into the experience of being a child taking part in a clinical trial designed to test new medication or vaccines – as well as the experience of deciding whether to allow your son or daughter to participate in such a study – is provided in two online resources launched this week.
Two new sections of the experiential health websites, www.healthtalkonline.org and www.youthhealthtalk.org, carry interviews with parents and children talking about how they found out about trials, why they decided to take part or, in some cases, decline an invitation to participate, as well as what information they needed and were given and how they felt about the experience.
The project has been produced with the support of the National Institute for Health Research (NIHR). Research was carried out by the Health Experiences Research Group, University of Oxford with carefully designed interviews of 29 parents as well as 32 children aged from ten upwards who have been on, or have been invited to participate in, a trial.
On the site, Dr William van’t Hoff, Co-Director of the NIHR Medicines for Children Research Network, acknowledges public anxiety about involving children in clinical research.
“There are real concerns about undertaking research on children, a feeling that they shouldn’t be experimented upon. Clinical research has also been slow to recognise that children are not small adults in the way their bodies respond to medication, how they absorb and metabolise it as well as the long-term effects.
As a result, however, half the medicines that we use in children haven’t been properly tested for this purpose and we rely on data from adult experience. That cannot be in the interests of children.”
Dr van’t Hoff underlines the importance of children being supported in giving informed consent in order for trials to be ethical and successful.
“It’s absolutely vital that the children and their parents receive and understand the information about the trial – with an on-going process of agreement to participation that continues through the study. Every child must be given the opportunity to withdraw at any stage and that is something that every researcher must understand and respect.”