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August 25, 1999

Are Surrogate Markers Adequate to Assess Cardiovascular Disease Drugs?

Author Affiliations

Author Affiliation: Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md.


Controversies Section Editor: Phil B. Fontanarosa, MD, Interim Coeditor.

JAMA. 1999;282(8):790-795. doi:10.1001/jama.282.8.790

The use of surrogate end points as a basis for reaching conclusions about the benefit of therapy has been met with both rising enthusiasm, reflected in recent changes in the Food, Drug and Cosmetic Act1 and some recent US Food and Drug Administration (FDA) actions, and rising concern, reflected in several strongly stated warnings.24 The mixed response is not surprising: reliance on surrogates, when the surrogate proves to predict clinical benefit, can bring treatment benefits to patients years before information on clinical outcomes could be available and at relatively low cost. But reliance on surrogates, when the effect on the surrogate does not lead to clinical benefit, can lead to the adoption of useless or even harmful therapies. The obvious community goal is to make decisions most likely to yield the former of these outcomes.

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