Phase 3

A phase of a clinical trial in which the experimental drug or treatment is given to large groups of people with the disease or condition being studied. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. If the results of clinical development, Phase 1 through 3, indicate that the investigational drug is safe and effective, the data are submitted to the Food and Drug Administration (FDA) as part of a New Drug Application or, in the case of a biologic, a Biologics License Application (BLA). FDA: Drug Approval Process Infographic; FDA: What Are the Different Types of Clinical Research?