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A patient is any individual with or at risk of a specific health condition, whether or not he or she currently receives any therapy to prevent or treat that condition. Patients are the individuals who directly experience the benefits and harms associated with medical products.
A participant in a clinical trial is not necessarily a patient, but a patient in a clinical trial is a participant. Although often used interchangeably as a synonym for participant, a healthy volunteer is not a patient.
U.S. Food and Drug Administration (FDA) Patient-Focused Drug Development Glossary