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‘s Maxine Dunitz Children’s Health Center.
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.
“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.”
Clinical trials explained
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.
Why clinical trials in kids are different
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 in a similar manner as those for adults, there are a few key caveats: