Families & Kids

What is a Clinical Trial?

A clinical trial is the process to test new methods for treating cancer. The new method may be a new approach to surgery or radiation, a new method of gene therapy, a new drug, or a combination of these. The goal of a clinical trial is to determine the safety of the treatment and how well it works to fight cancer. When a child is enrolled on a clinical trial he or she is observed closely by the treating physician and staff to see how the child is tolerating the treatment and the effect of the treatment on his cancer.

Your child will most likely be enrolled in a Phase I or Phase II clinical trial. Each Phase seeks to answer a different question about the disease or the treatment:

A Phase I Clinical Trial is one where a particular treatment that has already been studied in adult patients with cancer and has shown some positive response will now be studied in children. The study doctor will closely follow the child's care to evaluate side effects and make sure the new treatment is safe to give to children. The phase one trial primarily evaluates what dose of the new drug is safe to give children and there may also be additional blood work drawn to look at how the new treatment works in the body.
A Phase II Clinical Trial continues to study the safety of the drug, evaluates how effective the drug is for patients with a particular disease, and determines the short- term side effects and risks associated with the study drug or treatment. The study doctor will continue to follow your child closely to assess for possible side effects and make certain that the new treatment is safe.
A Phase III Clinical Trial studies a new drug, combination of drugs, or a new procedure in comparison to the current standard of care. The child may be assigned to the standard group or the new group at random (randomization). Generally a larger number of patients are enrolled in a Phase III trial than in Phase I or II trials.

Why Should I Enter My Child on a Clinical Trial?

Enrolling on a clinical trial may give your child access to new treatments not yet available to the public, and the opportunity to obtain expert medical care by a leading physician in the field of cancer research. You will also be helping others by making a valuable contribution to cancer research.

Is There a Down Side To Enrolling my Child on a Clinical Trial?

The clinical trial may require additional trips to the study site for treatments, blood work and tests required for the study. The treatment may not be effective for your child, or there may be side effects to the treatment.

In the event your child experiences side effects from the study drug, treatment will be provided and every effort made to minimize your child's discomfort.

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