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Phase IV trials are conducted after the new drug has been approved by the U.S. Food and Drug Administration (FDA). In these studies, the new drug is prescribed in an everyday health care environment, which allows for more information to be obtained about use of the drug in a larger group of patients.
Phase IV trials enable comparisons with other treatments for the same condition to be made and to determine the clinical effectiveness or safety of the new drug in a wider variety of patient types. Safety is a major part of Phase IV trials which often involve several thousand patients so that more rare side effects, if any, may be detected.
At UCB, our philosophy is to have a "one team" approach to drug discovery and development.