A systematic study designed to evaluate a product (drug, device, or biologic) to treat, prevent, or diagnosis a disease or condition in humans, which can be conducted only after approval by the U.S. FDA.
A study to evaluate a product, drug, or biologic, as determined by the products benefits relative to risks.
A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people.
Research in which an experimental drug is given to human subjects. Go to definition 21 CFR 312; go to full 21 CFR 312.