Informed Consent: Clinical Trials


If a clinical trial is available, it most likely contrasts what is currently considered the best available treatment with a treatment that is different in a way which is hoped to be better or make treatment for your child’s disease easier.

A newer treatment plan, also called the “investigational treatment,” may use a newer drug, a different combination of drugs or some other new approach.

When the investigational treatment is being compared to the standard treatment, it is because there is a good reason to think that the new treatment will be at least as effective as the standard treatment, but no one knows yet if it might be better in some way. The treatments are thought to be very close in terms of how well they work; that is why they are being compared to each other.

The best way to learn whether or not one treatment is better is by comparing the treatments in a clinical trial where some children receive the standard treatment and others receive the newer treatment. This is the way medicine usually advances. However, in such comparisons there are unknowns; that is why research is being done. One treatment may turn out to be better than the other or one may turn out to have fewer or more side effects. We do not know which is better, which is why this comparison trial is being done.

To keep the comparison of the treatments fair, clinical trials make assignments to one treatment or another by a process called “randomization.” That means that each child has an equal chance of receiving any one of the treatment plans in the clinical trial. Randomization is done by a computer – it’s a bit like flipping a coin. This idea can be hard to grasp for something as important as your child’s cancer treatment. But, it makes sense because both treatments are expected to be good for your child, but we don’t know if one may turn out to be slightly better than the other. If doctors notice that there are major differences between the treatments, children not already on the “better” treatment may be given the opportunity to switch to that treatment. Again, your doctor knows this and will expect you to ask any questions you need to in order to understand the clinical trial process.

History of Treating this Cancer

You can ask the doctor about the history of treating the type of cancer your child has and what the doctors have learned about it. Cancer treatment progresses step-by-careful-step as researchers learn what treatments or combination of treatments are most effective. Looking back on their consent conference, some parents said that it was very helpful for them to learn how current standard treatment plans were developed. For children’s cancer, this has been a step-by-step process over many years. It takes a long time because many children have to be compared on the two treatments to truly show a difference. Today’s successful standard treatments are possible because of the many thousands of families who participated in clinical trials in the past. You may feel more confident about making your own decision if you know how current treatment plans were developed.

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Making Treatment Decisions
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