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.
Learn more about safety and privacy for clinical trial participants