New online resources backed by the UK’s National Institute for Health Research (NIHR) seek to demystify paediatric trials for children and their parents, reinforce informed consent in this setting, and educate clinical research professionals about what matters to young study participants.
The resources have been launched as two new sections of the experiential health websites www.healthtalkonline.org and www.youthhealthtalk.org, run by Oxford-based charity DIPEx. The charity works with the Health Experiences Research Group at the University of Oxford to disseminate research into personal experiences of health and illness.
The new sections, Clinical trials: Parents’ experiences and Clinical trials in children and young people, feature interviews with parents and children addressing how they found out about clinical trials, why they decided to take part (or, in some cases, not to take part), the information they needed and were given about the trials, and how they felt about the whole experience.
Research for the project was carried out by the Health Experiences Research Group, which interviewed 29 parents and 32 children aged 10 years and over who had taken part, or been invited to participate in, a clinical trial.
The resources are designed to clarify the goals, circumstances and responsibilities of clinical trials that, as the NIHR points out, are gaining momentum on the back of the European Union’s regulation on paediatric medicines yet remain a source of public unease.
“There are real concerns about undertaking research on children, a feeling that they shouldn’t be experimented upon,” commented Dr William van’t Hoff, co-director of the NIHR Medicines for Children Research Network, which was set up in 2005 and has already seen 30,000 children recruited to clinical trials in the UK.
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”, van’t Hoff added.
As a result, “half the medicines that we use in children haven’t been properly tested for this purpose and we rely on data from adult experience”.
Professor Dame Sally Davies, chief medical officer and chief scientific adviser at the Department of Health, said the new sections of the DIPEx websites would help families who were thinking about participating in trials to make more informed choices.
They would 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”.
Consent is paramount
Informed consent, though, is paramount, van’t Hoff emphasised. “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.”
Moreover, he said, every child “must be given the opportunity to withdraw at any stage and that is something that every researcher must understand and respect”.