Clinical Trials are part of Clinical Research. Clinical research studies (also known as clinical trials) begin with an idea. These ideas often originate in the laboratory. New therapies or procedures are tested in the laboratory and in animal studies. If the initial laboratory research is successful, researchers send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans. The next steps in a clinical trial of a new drug being tested in humans involve collecting data that will help determine whether a drug is safe and effective. Clinical trials are conducted in phases. Typically there are four phases. During a trial, more information is gained about an experimental treatment, device or intervention, its risks, and its effectiveness. Data from each phase of a clinical trial is submitted to the FDA for review before the next phase of the study can begin.
Many Different types of people participate in clinical trials. Some are healthy, while others may have illnesses. A healthy volunteer is a person with no known significant health problems who participates in clinical trials to test a new drug, device or intervention. Healthy volunteers have always played an important role in research.