WHAT ARE CLINICAL TRIALS?
Clinical trials are research studies in which volunteers receive new drugs or other treatments so that scientists can evaluate how well the treatments work. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective in people. In addition to taking the drugs or treatments being tested, participants may help measure results by reporting on how they feel and by allowing providers to conduct follow-up exams that might include blood tests or other testing.
Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test safety and performance. If these studies show favorable results, the FDA gives approval for the treatment to be tested in humans, beginning with a very small participant population to test safety.