Trials within children and young people’s cancer are often designed by a group of national and international experts after much discussion and preliminary studies. Within the United Kingdom (UK) most of these cancer trials are sponsored by the Cancer Research Clinical Trials Unit in Birmingham. An increasing number of trials are also designed and sponsored by pharmaceutical companies. Once the trial protocol (plan of treatment) has been decided on, it is then reviewed by an Ethics Committee who decide whether the trial is safe, relevant and in the best interest of the patient before the trial is open to recruitment.
Any one trial is usually open for recruitment at all the larger Principal Treatment Centres treating children and young people with cancer in this country and often throughout Europe. The more patients who are treated in a trial the quicker an answer is obtained. Nevertheless, in some trials it can still take several years to get results. Whilst a trial is running the results are reviewed regularly. If a difference appears between the results of the new treatment and the standard treatment – for example, if it is better, or more toxic – this is acted upon and all patients receive what is then recognised as the best treatment.
Within the UK it is usual for all of the 19 cancer treatment centres to have access to the same clinical trials, meaning a child or young person will be offered access to the same trial, no matter where they live. It is not possible for early phase studies to be open in every centre, but if an early phase study is an option for a patient it is usual practice for them to be referred to the closest recruiting site. Some of these hospitals are known as Experimental Cancer Medicines Centres (ECMCs)
A patient will not be entered into a trial without the trial being explained as fully as possible and informed consent obtained. If there is a suitable trial, a research nurse will spend time explaining the trial to the patient and their family. A General Practitioner information sheet will be provided if a patient is enrolled in a clinical trial.
If the patient and their family do not want to give consent, for whatever reason, this is completely acceptable and they will be given the best known standard treatment. Parents/carers are reassured that consent can be withdrawn at any time without explanation.
Sometimes being in a trial on a new treatment means extra tests are needed so that we can monitor all aspects of the new treatment.
If you would like further information on a particular trial, please contact the patient’s Paediatric Oncology Outreach Nurse Specialist (POONS) or the Children’s Cancer Research Nurse at the Principal Treatment Centre.
Further information
Children’s Cancer and Leukaemia Group (CCLG) research
Taking part in clinical trials (CCLG)
CCLG factsheet 'A guide to clinical trials'