Why Is Clinical Research In Children Essential?

It's essential to study new treatments in children because children are not little adults. Children have different treatment needs than adults, and sometimes they have other diseases than adults. Also, doses of medicine, sizes of devices, or types of therapy may change over time according to each child's needs and stage of growth and as more information about the side effects and usefulness of a drug becomes available over time.

A successful clinical trial can create a new standard of care for children with certain conditions. Without a standard of care for children with certain conditions, treatment for children may need to be based on what works for adults. For example, most medicines given to children as part of standard treatments have only been tested in adults. When medicine that has been tested only in adults is given to children, this is called off-label use of the medicine.

In recent years, laws have been passed that require pediatric clinical trials for specific conditions. As a result, the number and range of clinical trials for children have expanded. Each clinical trial follows a detailed plan called a protocol. A protocol is carefully designed to minimize the study's risks, increase the chance of getting useful results, and answer specific research questions. It includes a description of who can and cannot participate, the likely length of the study, information about what is being tested, and how the information will be collected. Before clinical trials of new medicines begin, these medicines are first tested and studied in a laboratory and in animals.

Source: Healthy Children by the American Academy of Pediatrics