A clinical outcome is a measurable change in symptoms, overall health, ability to function, quality of life, or survival outcomes that result from giving care to patients. Clinical outcomes may be used in clinical settings, such as a hospital or doctor’s office, to measure the success of care or to assess a person’s response to an already approved treatment. One or more clinical outcomes may be used in clinical trials as an endpoint to determine how well a new therapy works and/or the safety of a new therapy.
U.S. Food and Drug Administration (FDA) Patient-Focused Drug Development Glossary
Glossary from “BEST (Biomarkers, EndpointS, and other Tools) Resource” [Internet].
U.S. Food and Drug Administration (FDA): Multiple Endpoints in Clinical Trials Guidance for Industry
U.S. Food and Drug Administration (FDA): Surrogate Endpoint Resources for Drug and Biologic Development