Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2000;1(2):76-78.
doi: 10.1186/cvm-1-2-076.

Debate: The slippery slope of surrogate outcomes

Ralph B D'Agostino Jr  1
Affiliations

Debate: The slippery slope of surrogate outcomes

Ralph B D'Agostino Jr. Curr Control Trials Cardiovasc Med. 2000.

Abstract

Surrogate outcomes are frequently used in cardiovascular disease research. A concern is that changes in surrogate markers may not reflect changes in disease outcomes. Two recent clinical trials (Heart and Estrogen/Progestin Replacement Study [HERS], and the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial [ALLHAT]) underscore this problem since their results contradicted what was expected based on the surrogate outcomes. The current regulatory policy to allow new therapies to be introduced onto the market based solely on surrogate outcomes may need to be reviewed.

PubMed Disclaimer

References

    1. Buehler JW, Mulinare J. Preventing neural tube defects. Pediatr Ann. 1997;26:535–539. - PubMed
    1. Ewan PW. Prevention of peanut allergy. The Lancet. 2000;352:4–5. - PubMed
    1. Fleming TR, DeMets DL. Surrogate end points in clinical trials: are we being misled. Ann Internal Med. 1996;125:605–613. - PubMed
    1. Sobel BE, Furberg CD. Surrogates, semantics, and sensible public policy. Circulation. 1997;95:1661–1663. - PubMed
    1. Psaty BM, Weiss NS, Furberg CD, Koepsell TD, Siscovick DS, Rosendaal FR, Smith NL, Heckbert SR, Kaplan RC, Lin D, Fleming TR, Wagner EH. Surrogate end points, health outcomes, and the drug-approval process for the treatment of risk factors for cardiovascular disease. JAMA. 1999;282:786–790. doi: 10.1001/jama.282.8.786. - DOI - PubMed

LinkOut - more resources