What is a clinical research study?
A clinical research study, also called a clinical trial, looks at an investigational drug or medical device to see if it is safe, how it works in the body, and if it works to treat a specific disease. The term “investigational” means that the drug or medical device being studied for use in a condition or disease has not been approved by the country-specific regulatory health authority, such as the Food and Drug Administration (FDA) in the United States. Clinical research studies are conducted by doctors who are responsible for the study participants’ study-related care. In most countries, the regulatory health authority requires that several phases of clinical research be performed to better understand the safety and effects of new investigational drugs and certain medical devices.
Why are clinical research studies needed in infants and children?
Children are not small adults. As a result, adult treatments may not always work the same way in children or some formulations may be better suited for children. Some conditions affect only children, so it is important for researchers to understand the most safe and effective dose of medication for children across all age ranges.
What should I expect for my child?
Before your child participates in a study, a detailed description of the study, as well as possible risks and benefits, will be provided in writing in an "informed consent form" and discussed with you.
You will be asked to review and sign the parental or legal guardian informed consent form prior to participating.
Your child’s medical history will be reviewed, and he or she will be given a study-related physical exam and laboratory tests.
Throughout the study, you should feel free to discuss your child’s care with the study doctor or research staff members at any time. You will also have the right to withdraw your child from the study at any time.