Debate: The slippery slope of surrogate outcomes.
Debate: The slippery slope of surrogate outcomes.
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DOI：
10.1186/cvm-1-2-076
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发表时间：
2000-01-01
影响因子：
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通讯作者：
D'Agostino, Ralph B Jr
中科院分区：
文献类型：
--
作者：
D'Agostino, Ralph B Jr
替代结果经常用于心血管疾病研究。令人担忧的是，替代标志物的变化可能无法反映疾病结果的变化。最近的两项临床试验（心脏和雌激素/孕激素替代研究 [HERS] 以及抗高血压和降脂治疗预防心脏病试验 [ALLHAT]）强调了这个问题，因为它们的结果与基于替代结果的预期相矛盾。目前允许仅根据替代结果将新疗法引入市场的监管政策可能需要进行审查。
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.