Surrogate endpoints and FDA's accelerated approval process
Surrogate endpoints and FDA's accelerated approval process
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DOI：
10.1377/hlthaff.24.1.67
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发表时间：
2005-01-01
期刊：
影响因子：
9.7
通讯作者：
Fleming, TR
中科院分区：
文献类型：
--
作者：
Fleming, TR
人们对能够更快地提供新的干预措施的方法感兴趣，特别是对于有死亡或严重疾病风险的疾病。加速批准监管程序旨在满足这一需求，允许销售对生物活性指标有强烈影响的干预措施，如果这些指标是实际临床获益真实指标的潜在“替代品”。为了使用替代终点和加速审批过程，必须解决具有挑战性的问题，以避免损害真正符合公共卫生最佳利益的东西：对干预措施的安全性和有效性进行可靠和及时的评估。
There is interest in approaches allowing more rapid availability of new interventions, particularly for diseases providing risks of death or serious illness. The accelerated-approval regulatory process is intended to address this need by allowing marketing of interventions shown to have strong effects on measures of biological activity, if those measures are potential "surrogates" for true measures of tangible clinical benefit. To use surrogate endpoints and the accelerated-approval process, challenging issues must be addressed to avoid compromising what is truly in the best interest of public health: the reliable as well as timely evaluation of an intervention's safety and efficacy.