The U.K.’s DIPEx charity has launched two online resources to offer insight into the experience of being a child taking part in a clinical trial and the experience of deciding whether to allow your son or daughter to participate in such a study.
Two new sections of the experiential health web sites www.healthtalkonline.org and www.youthhealthtalk.org now 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, what information they needed and were given and how they felt about the experience.
“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,” said Professor Dame Sally Davies, chief medical officer and chief scientific adviser at the Department of Health. “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 has been produced with the support of the National Institute for Health Research (NIHR). Research was carried out by the Health Experiences Research Group at the University of Oxford, with interviews of 29 parents and 32 children ages 10 and up who have been in, or have been invited to participate in, a trial.
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 recognize that children are not small adults in the way their bodies respond to medication, how they absorb and metabolize it, as well as the long-term effects.”
The Network, set up in 2005 by the NIHR to promote properly designed and coordinated studies in the field, has already seen 30,000 U.K.children recruited to participate in clinical trials. With legislation requiring new medicines be tested on children, many thousands more will be invited to take part in trials.
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 children and their parents receive and understand information about the trial, with an ongoing process of agreement to participation that continues through the study,” he said.
Joe, 15, said he was “overwhelmed” when he was invited to take part in a trial after being newly diagnosed with juvenile diabetes at age 14. But he had no regrets; having to stay in the hospital as part of the trial enabled him to be better informed about managing the condition.
Mohini, 12, described her annoyance when her parents were the first to hear about a clinical trial to test new medication for acute lymphoblastic leukemia after she was diagnosed with the disease at age nine. But she was pleased her parents gave her the final decision, realizing “that I was mature enough and it was my life I was playing with.” She has no regrets about her decision to decline participation on the grounds that she preferred to know what treatment she was receiving and did not want to be randomized.
Alison made decisions on behalf of her son, who has cystic fibrosis, when he entered a trial for gene therapy at age eight. By age 12, she was “withdrawing from the room if the doctor was in there, if (my son) wanted me to (go).” When he was 16, she signed a form giving him full consent.
Louise Locock, deputy research director of the Health Experiences Research Group, said parents enroll their children in trials for the same mixture of reasons as adults. “They hope the child will benefit, as well as strongly wanting to help to advance clinical research for the sake of others.”