If your child is suffering from a serious condition such as asthma, irritable bowel syndrome or even seasonal allergies, you may wonder if they’re eligible to participate in a clinical trial. It’s important to note that clinical trials for children are different than trials for adults.
“Your child isn’t the same as an adult—they’re not even the same as other children. Infants react differently to interventions than their school-aged counterparts, and adolescents respond differently than those who are in puberty,” says Dr. Irina Dralyuk, a pediatric pulmonologist in Cedars-Sinai Guerin Children’s.
But like clinical trials for adults, pediatric trials could offer children a chance to receive beneficial treatment—a new drug, therapy, device or procedure—before it becomes widely available.
The goal of clinical trials is to advance scientific knowledge, but not all clinical trials are created equal. Some are noninvasive and require little involvement from study participants. Others test the effects of new therapies, vaccines and procedures and may call for multiple clinic visits, uncomfortable tests and treatments that produce side effects.
All studies follow an established protocol that outlines what the trial aims to uncover, who is an ideal candidate, which treatments (if any) are being tested and how the results will be assessed. In randomized and controlled clinical trials performed in adults, researchers separate participants into two groups: an experimental group that receives the treatment under investigation and a control group that receives standard treatment or a placebo (water pill).
A randomized, double-blind clinical trial, for example, randomly distributes study participants to receive either the placebo or the experimental treatment. In these trials, neither the patients nor the researchers know who received the treatment and who received the placebo until the study is complete. At the end of the trial, researchers analyze the results to determine whether the new treatment is effective.
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Children are a complicated group to study. Researchers can’t lump all children into one bucket—testing a treatment on a 17-year-old is not the same as testing a treatment on an infant. That’s just one reason for the seven-year lag time (on average) between an adult approval and a pediatric approval for the same agent—that means adults have access to effective treatments years before they’re available to children.
“Principal investigators for pediatric trials provide focused care and attention to kids in these trials simply because children’s bodies and minds are still developing,” says Dr. David Ziring, associate director of the Pediatric Inflammatory Bowel Disease Program at Cedars-Sinai.
So, while clinical trials for children are run similarly to those for adults, there are a few key caveats:
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 specific to children.
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 or your local hospital. 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.”
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:
Then, if you really want to know the specifics, you can delve deeper with this set of questions:
Learning as much as possible before enrolling your child in a trial offers the best odds of success.
“When you review the informed consent with the physician who is running the trial, it’s important to ask not only about the risks and benefits of participation but also the risks and benefits of not participating—and what alternatives are available to your child,” Dr. Ziring says.
Remember, too, that every trial, invasive or not, is completely voluntary. You or your child can decide to withdraw from a clinical trial at any time, and for any reason. Your child’s health—mental, emotional and physical—always comes first.
For more information on clinical trials, discover our Black Clinical Resource Center.
By Cedars-Sinai
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