Healthtalkonline press release
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.
Two new sections of the experiential health websites, www.healthtalkonline.organd 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.
Welcoming the new sites, Professor Dame Sally Davies, Chief Medical Officer and Chief Scientific Adviser at the Department of Health, said:
“Well designed trials are a vital contribution to advancing medical knowledge in order to improve treatment, care and quality of life for patients. Children have their own specific needs and we need more trials in children to be sure that we are getting the best treatments that work for them and aren’t just relying on evidence from adult trials.
These two new sections will be a valuable resource to help other families thinking about taking part in a trial to make a more informed choice, and to learn more about trial methods and what they can expect if they take part. The project will also provide a valuable teaching aid for professionals by offering insights in what really matters to parents and young people when they are invited to participate in a trial.”
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.”
The Network, set up in 2005 by the NIHR to promote properly designed and coordinated studies in the field, has already seen 30,000 UK children recruited to participate in clinical trials. With EC legislation requiring new medicines to be tested on children, many thousands more are set to be invited to take part in trials in future to ensure that newly developed medicines are safe and effective for 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.”
Clinical trials in children and young people
Notes to Editors
Medicines for Children Research Network
The Medicines for Children Research Network is part of the National Institute for Health Research. We provide researchers with the practical support they need to make clinical studies happen in the NHS, so that more research takes place across England, and more patients can take part.
Great Ormond Street Hospital for Children NHS Trust is the country’s leading centre for treating sick children, with the widest range of specialists under one roof.
With the UCL Institute of Child Health, we are the largest centre for paediatric research outside the US and play a key role in training children’s health specialists for the future.
Our charity needs to raise £50 million every year to help rebuild and refurbish Great Ormond Street Hospital, buy vital equipment and fund pioneering research. With your help we provide world class care to our very ill children and their families.