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Clinical Trials

Clinical Trials



Cancer doctors (Oncologists) are always looking for new drug and drug combinations to treat cancer. A controlled clinical trial is the only reliable way of testing a new treatment. Often several hospitals around the country, as well as overseas, take part in these trials. Participation in clinical trials enables access to the most up to date treatment available. The Children's Cancer Centres at The Royal Children's Hospital and Monash Medical Centre strongly support children being enrolled on a clinical trial.

There are four types of clinical trials in children's cancer. A Phase 1 trial, rarely performed in children, is to find out about the side effects and the acceptable doses of new treatments. A Phase 2 trial aims to find out how well the new treatment works. A Phase 3 trial compares the treatment with the standard one. A Phase 4 trial is after a drug has been approved and is on the market.

In a clinical trial, the type of treatment your child receives may be decided at random- by chance, using a computer- not by the doctor treating your child, and not by you or your child.

In some trials, one group of patients receives the best standard treatment, while the other group receives a new kind of treatment which may or may not prove to be better than the standard treatment. If the new treatment does turn out better it may be because it is more effective against the cancer or because it is equally effective but has fewer side effects.

The reason your consultant Oncologist would like children to take part in a clinical trial is because until a new treatment has been tested scientifically in this way it is impossible for doctors to know which treatment is better. Today's trial treatment could be tomorrow's standard treatment.

Before a clinical trial is allowed to start it must be approved by the hospital's Ethics Committee. Then the treatment details are explained to you and you are given written information to read. For a child to be enrolled in a clinical treatment you or your spouse (parent/guardian) needs to sign a consent form that will be explained to you by your doctor. If your child is old enough to understand this process, he/she may also be asked to sign the consent.

The results of the clinical trial will not be known until the patients have completed the treatment course. However, records are reviewed during each study, and if important information is discovered, this will be shared.

Your child can be withdrawn from the trial at any time. You may decide not to allow your child to take part in a clinical trial. It is important to know you have a choice, whatever your decision your child will still get the best known established treatment.

For more information regarding clinical trials please refer to
The Information Book Edition 2.1, Section 4:3.

The following websites provide information about clinical trials:
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