If you’re considering a clinical trial for a child, it may be helpful to understand why we run these trials in the first place. Sometimes it’s because certain conditions are especially common in children. More generally, it’s because children need treatments studied specifically for them. Their bodies are still developing, and medicines used to treat adults may not affect children in the same way that they affect adults.
A pediatric clinical trial could help us develop the correct dose of a medicine for a child, or it could focus on development of a liquid formulation that is easier to swallow. Participation from children in clinical trials helps us develop medicines that are safe and effective for children.
Pediatric clinical trials & children’s safety
Your child’s safety is top of mind for you.
Pediatric clinical trials are designed and conducted with children in mind. As with clinical research with adults, it begins with a protocol — the detailed plan for the study and schedule of study activities. However, a pediatric study is designed with special considerations for children. For example, needle pokes are minimized when possible, and the amount of blood taken during the study may be limited based on the age of the child.
Pediatric clinical trials have additional safety guidelines. As with clinical trials with adult participants, the guidelines are governed by regulatory agencies such as the U.S. FDA, and oversight is provided by institutional review boards or independent ethics committees. In addition, the regulatory agencies require pediatric-specific drug development plans that are reviewed and agreed to by the agencies’ own pediatric experts.
Every clinical trial has an informed consent document that provides details about the study. The study team can answer any questions you or your child have about the study.
Pediatric clinical trials & children’s safety
Informed consent & a child participant’s assent
Informed consent & a child participant’s assent
Legally, children are not able to provide informed consent until they reach adulthood. However, children who are old enough and able to do so provide something called assent. Assent is when the child understands and agrees to take part in the clinical trial. Assent forms are age-appropriate and provide information on clinical trials in a format that children can easily understand.
Once a child gives assent to participate, the parents or legal guardians are the ones who provide consent for their child to participate in the trial.
Informed consent & a child participant’s assent
Ways to talk to your children about clinical trials
Shaman’s Magic Dream
Do children know where the medicines they take when they’re sick come from? How do they know that the medicines help make them better? Who made it possible for the medicines to be in their medicine cabinets?
These are some of the questions we explore in Shaman’s Magic Dream, an educational tool we created to make it easier for you to discuss clinical trials with your child.
Sophie’s Science Project
Another tool is Sophie’s Science Project, developed by Boston Children’s Hospital in partnership with the Children’s Hospital of Philadelphia and Cincinnati Children’s Hospital. This comic book educates children about medical research and the assent and informed consent process.