Table 1 National Institutes of Health–recommended definitions of outcome measures[26]
From: Translational toxicology: a developmental focus for integrated research strategies
Outcome | Definition |
|---|---|
Clinical end point | "A characteristic or variable that reflects how a patient feels, functions, or survives." |
Surrogate end point | "A biomarker that is intended to substitute for a clinical end point. A surrogate end point is expected to predict clinical benefit (or harm or lack of benefit or harm) based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence." |
Biological marker (biomarker) | "A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention." |