A clinical trial is a research study. Researchers use clinical trials to:
Some trials look at ways of reducing the side effects of treatment. Often, clinical trials have questions about treatment, diagnosis and supportive care all within the one trial.
Researchers run most clinical trials at a number of institutions around the world at the same time. That means trial questions can be answered accurately and in a reasonable timeframe. Clinical trials have played a huge role in the dramatic improvements in childhood cancer cure rates in the last 30 to 40 years.
There are 3 phases of a clinical trial.
These study brand new medicines.
These study medicines which have graduated from phase 1 trials. Researchers test the medicines with a greater number of people and sometimes with different doses.
These are the ones that most children are enrolled in. Researchers compare what has been used as the 'standard treatment' with a new form of treatment. In this way, the trial is a refinement rather than experimentation.
To make comparisons between treatments, patients in a trial receive one treatment or the other. This means that one group of children will receive 'treatment A' and another group will receive 'treatment B'. Sometimes there are more than 2 groups. A computer makes the selection. The computer has no information about your child - the decision is random.
The results of the research and treatment will not be available until all the patients have completed the treatment course. This may take several years. But researchers regularly review the records during the trial. If they discover important information, they tell each doctor involved. The doctors will share this with participants. That way, they share all the findings.
You do not have to consent to your child joining a clinical trial. If you do, you can withdraw your child from the trial at any time. If this happens, your child will receive the standard treatment.
Your child's doctor will explain everything to you and provide all the information you need to help you to make an informed decision.
Also, there is an information sheet for each clinical trial. It details the course of treatment (called the protocol), possible side-effects and any necessary tests. It will also tell you what information and specimens will be collected and sent to the overseas centre.
Read more about childhood cancer treatments [1]
Here are some of the questions you may wish to ask your doctor. You may also want some of the medical terms explained.
There are safeguards in place to protect patients participating in clinical trials. The 3 main ones are:
Informed consent is a process. Your doctor and other health professionals will share information and advice with you and your child. The information and advice will help you both to decide whether or not to consent to being part of a clinical trial.
The ethical basis for the principle of informed consent comes from Right 7 of the Code of Health and Disability Services Consumers' Rights. You can ask for a copy of the Code at your hospital.
Every clinical trial requires careful assessment by a health and disability ethics committee. It is the responsibility of the committee to make sure that it is ethically acceptable for children to participate in the trial. Even though most clinical trials are developed overseas, a New Zealand ethics committee must review each trial before it gets approval in this country.
A number of other national and regional organisations will also be involved with the review process.
A Māori consultant or a Health Research Committee which is iwi representative also reviews clinical trials for cultural acceptance.
All the pages in the childhood cancer section of this website [2] have been written by health professionals who work in the field of paediatric oncology. They have been reviewed by the members of the National Child Cancer Network (NZ). Medical information is authorised by the clinical leader of the National Child Cancer Network.
This page last reviewed 13 May 2021.
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Links
[1] https://www.kidshealth.org.nz/tags/childhood-cancer-treatments
[2] https://www.kidshealth.org.nz/tags/childhood-cancer
[3] https://www.kidshealth.org.nz/node/1525?language=ko
[4] https://www.kidshealth.org.nz/contact?from=http%3A%2F%2Fwww.kidshealth.org.nz%2Fprint%2F463%3Flanguage%3Dko