Surrogate endpoint
Surrogate endpoint is a term used in clinical trials to refer to a biomarker or physical sign that is used as a substitute for a clinically meaningful endpoint that measures directly how a patient feels, functions, or survives. Changes induced by a therapy on a surrogate endpoint are expected to reflect changes in a clinically meaningful endpoint.
Definition[edit | edit source]
The Food and Drug Administration (FDA) defines a surrogate endpoint as "a laboratory measurement or physical sign that is used in therapeutic trials as a substitute for a clinically meaningful endpoint that is a direct measure of how a patient feels, functions, or survives and is expected to predict the effect of the therapy".
Use in clinical trials[edit | edit source]
Surrogate endpoints are used in clinical trials to decrease the time it takes to see the effects of a treatment. For example, in trials of cholesterol-lowering drugs, it would take many years to see a decrease in the number of heart attacks or strokes. Instead, the level of cholesterol in the blood is used as a surrogate endpoint.
Criticism[edit | edit source]
The use of surrogate endpoints has been criticized because they do not always accurately predict the clinical outcome. For example, a drug might lower cholesterol (the surrogate endpoint) but not actually reduce the number of heart attacks or strokes (the clinical outcome).
See also[edit | edit source]
References[edit | edit source]
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