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

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

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

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

• Clinical endpoint
• Biomarker
• Food and Drug Administration

References

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