Patient Participation in Clinical Trials
Why Do Research In Children?
Medicines, devices, and treatments are often not tested in children.
At nearly half of medical visits, children are given a medicine, and 70% of those medicines have only been tested in adults.
The simple truth is…children are not little adults.
But without research involving children, we have no choice but to treat them that way.
Doctors and advanced practice providers (e.g. nurse pratictioners and physicians assistants) often give medicines to children even though they have not been studied and approved by the Food and Drug Administration (FDA) for use in children. This is known as “off-label” use. Most of the time, this works well, but when the adult dose is adjusted to the weight of a child, there is a chance that the dose used could be ineffective or even harmful.
This approach may sound like guesswork, but without research in children, it’s all we have. We need to think about how a child’s brain and body are developing…as well as the way a child’s body handles medicines and other treatments over time.
Why Clinical Studies Are Important
Clinical research in children helps us to treat our children like children, rather than as little adults, in several ways:
- it uncovers the best dose of medicines to prevent harmful effects or under-treatment;
- it leads to the development of chewables, liquids, or tablets that are easier for children to take, yet still safe;
- it results in treatments for problems that occur only in children, like prematurity;
- it leads to treatments for diseases or conditions that occur in both children and adults but that act differently in children and adults, like arthritis or heart disease;
- it results in treatments for new or existing diseases that improve the health of children in the future, like vaccine studies that were done years ago and help children stay healthier today; and
- clinical research in children help us understand how medicines affect children’s brains and bodies as they grow and develop.
Pediatrician Clinician-researchers, doctors, and nurses talk about the importance of conducting clinical trials for children while addressing common questions that parents and caregivers face.
For more information: National Heart, Lung, and Blood Institute, National Institutes of Health www.nhlbi.nih.gov/childrenandclinicalstudies