Information on Clinical Research Studies
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.
Children are not little adults. But without clinical research in children themselves, we have no choice but to treat them that way.
Doctors and nurses 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.
Clinical research in children helps us to treat our children like children, rather than as little adults, in several ways:
A clinical investigator is a medical researcher who is in charge of conducting a clinical trial and ensuring the well-being of study volunteers. Researchers are usually doctors, nurses, pharmacists, or other health care professionals
Anyone entering a clinical clinical research study in the United States is required to sign a form indicating that they understand what will happen to them during the clinical research study. If the patient is a child, a parent or guardian as well as the child must sign the form. This form will tell you what study drugs will be given, what kind of problems might occur, and what other treatments might work for your condition. The amount of help expected from the clinical research study will be given if any. The informed consent form also indicates which costs are covered by the clinical research study and which must be paid by you (or your insurance).