What are the “phases” of clinical research trials?
Clinical trials are conducted in phases, with each phase a different stage of testing. The trials at each phase have a different purpose and help scientists answer different questions. In Phase I trials—Researchers test an experimental drug or treatment in a small group of people (20–80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase II trials—The experimental study drug or treatment is given to a larger group of people (100–300) to see if it is effective and to further evaluate its safety. In Phase III trials—The experimental study drug or treatment is given to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely. In Phase IV trials—After a drug is licensed (approved by the FDA) or treatment is launched, researchers track its safety, seeking more informat
