If your son or daughter is struggling with a serious illness like cancer or
has a chronic condition like asthma, your doctor might talk to you about enrolling
your child in a clinical trial.
About Clinical Trials
A clinical trial is a research study that follows a predefined protocol, or plan
of action.
Some clinical trials observe people in certain situations (for example, how many
overweight or obese kids become depressed) and then record the outcomes for study
investigators to analyze. Others test the effects of potential new drugs, therapies,
vaccines, vitamins, or procedures. These types of trials, called randomized, controlled
clinical trials, try to find the best treatment with the fewest side effects. They
begin only after early research has been done and there is reason to believe that
a potential new treatment is effective.
All clinical trials are voluntary and information collected during them is confidential.
Participants can withdraw from a trial at any time, for any reason.
How They Work
All studies are led by a protocol, which establishes what the trial will study,
who is a good candidate for the study, what treatments (if any) will be used, and
how results will be measured.
In a randomized, controlled clinical trial, children are separated into groups.
The experimental group(s) will receive the treatment that is to be tested, while the
control group(s) will get the usual treatment (usually what a child is already
taking) or placebo (a fake treatment or sugar pill that contains no medicine at all).
In clinical trials on children, placebo is used only if the lack of treatment is
short (perhaps a few days) and poses minimal risks, or if the therapy being tested
is used to only treat uncomfortable symptoms (like watery eyes) and not a severe illness.
In these types of trials, patients are "blinded," which means they don't know who
is getting the treatment and who is getting the placebo until the trial is over. That
way, their perceived response to the drug or placebo can't be influenced by whether
they think they have been taking the real drug or not. In a double-blind study, neither
the patients nor the researchers know who has taken the drug or the placebo until
the study is over.
Once the study is over, the outcomes of the experimental group and the control
group are compared. Researchers analyze the data to determine if the potential new
treatment is effective.