An FDA primary outcome refers to the primary endpoint or measure that is used to evaluate the effectiveness of a drug or medical device in a clinical trial that is regulated by the US Food and Drug Administration (FDA).
The FDA requires that clinical trials conducted for the purpose of evaluating the safety and efficacy of a drug or medical device include one or more primary outcomes that are clearly defined and measurable. The primary outcome(s) should reflect the main goal or objective of the study and be relevant to the patients being treated.
The selection of a primary outcome is an important part of the design of a clinical trial, as it determines the statistical analysis and the sample size required to detect a significant treatment effect. The FDA typically requires that the primary outcome be a validated and reliable measure, and that it be clinically meaningful and relevant to the patient population being studied.
Examples of FDA primary outcomes might include measures of symptom severity, disease progression, functional status, quality of life, or survival rates, depending on the specific condition being treated and the goals of the study.