- Informed consent: Depending on the age of the child, both the participating child and the child’s parent need to consent to participate in the study. Older children and teenagers complete a separate informed consent. “We need to know they’re willing to participate in the trial,” Dr. Ziring says.
- Children’s trials come last: Studies that are randomized and controlled set out to identify effective treatments for a particular condition. These trials occur only after preliminary research shows the agent is safe and effective in the lab, then in animals and finally in adults. “Kids are always the last to get tested with a new treatment,” says Dr. Dralyuk. “By the time researchers begin trials for children, we know the intervention is safe and effective in adults.”
- Placebo use: Clinical trials for children generally don’t include placebos. “If there’s evidence that a treatment works well in adults, it’s not ethical to expose a child to a placebo and withhold a treatment that could improve their condition,” says Dr. Ziring.
Investigators who conduct clinical trials in children also pay particular attention to child development, including bone growth, hormonal changes, social and emotional development and other considerations that are specific to children.
How to find trials
Finding clinical trials that are relevant for your child may require some investigating. The first step for many parents is the government’s repository of health trials at clinicaltrials.gov.
“That’s the most comprehensive source of information about clinical trials,” says Dr. Ziring.
If that process feels too overwhelming, talk to your child’s doctor and ask about relevant trials at Cedars-Sinai and other major centers. Often, your child’s physician is better equipped to identify appropriate trials.
For children who have a specific condition, such as cystic fibrosis, leukemia or cerebral palsy, parents may be able to tap into national foundations and nonprofit organizations dedicated to the disease for information about relevant clinical trials.
“If you’re interested in clinical trials testing a specific drug, you can also do an internet search of the medication’s name,” Dr. Dralyuk says. “In many cases, pharmaceutical companies provide information or links to clinical trials investigating their treatments.”
What you should know before you enroll
Clinical trials provide an avenue for patients to help advance scientific knowledge. Your child’s participation could result in scientists discovering a more effective treatment for diseases that affect children all over the globe—and it could treat their disease more effectively than standard protocols.
Still, there are risks involved with participation, too. In addition to potential side effects of experimental therapies, children may be subjected to the emotional and mental toll of frequent clinic visits, blood draws and assessments.
“That’s one reason these trials include incentives,” Dr. Ziring says. “It’s not to entice parents to enroll their child in the study, but rather to compensate them for their time and effort, and for the discomfort and inconvenience involved with participation.”
Before you decide to enroll your child in a clinical trial, make sure you get answers to three key questions: