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The four phases of clinical trials. Tens of thousands of treatments to prevent and treat diseases are available to people today. How do we know that they are safe and work well? Clinical trials. A clinical trial is a research study that tests new treatments or medical devicesin people who volunteer to take part. To be approved for use, the results from clinicaltrials must show that a new treatment is safe for people to take and works well. Only then can the U.S. Food and Drug Administration (or FDA) approve it for use by the public. The FDA is the government agency that protects the publics health by reviewing and approving treatments, medicines and other medical products. How do clinical trials test new treatments? Most new treatments go through four phases of clinical trials. Each phase has different goals, and a treatmentwill only move to the next phase if resultsshow it is safe and works. The most important thing to researchers is participants safety. They design clinical
