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 a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. These studies are performed under the care and supervision of a physician referred to as the Principal Investigator of the trial. They are the primary way that researchers find out if a new treatment option, like a new drug, diet or medical device (for example, a pacemaker) is safe and effective in people with certain health conditions. Often a clinical trial is used to learn if a new treatment option is more effective and/or has less harmful side effects than the standard treatment currently available on the market.
What are the four phases of clinical trials?
Clinical trials advance through four phases (Phase I, II, III, and IV) to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA approves it for clinical use and continues to monitor its effects.