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首页> 美国卫生研究院文献>PLoS Medicine >The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011–2018
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The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011–2018

机译：在两个欧洲药品管理局的加速批准途径中使用经过验证的和未经验证的替代终点：对2011-2018年授权产品的横断面研究

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BackgroundIn situations of unmet medical need or in the interests of public health, expedited approval pathways, including conditional marketing authorisation (CMA) and accelerated assessment (AA), speed up European Medicines Agency (EMA) marketing authorisation recommendations for medicinal products. CMAs are based on incomplete benefit-risk assessment data and authorisation remains conditional until regulator-imposed confirmatory postmarketing measures are fulfilled. For products undergoing AA, complete safety and efficacy data should be available, and postauthorisation measures may include only standard requirements of risk management and pharmacovigilance plans. In the pivotal trials supporting products assessed by expedited pathways, surrogate endpoints reduce drug development time compared with waiting for the intended clinical outcomes. Whether surrogate endpoints supporting products authorised through CMA and AA pathways reliably predict clinical benefits of therapy has not been studied systematically. Our objectives were to determine the extent to which surrogate endpoints are used and to assess whether their validity had been confirmed according to published hierarchies.
机译：背景技术在医疗需求未得到满足或符合公共卫生利益的情况下，加快批准途径，包括有条件的市场许可（CMA）和加速评估（AA），可以加快欧洲药品管理局（EMA）的药品市场许可建议。 CMA基于不完整的收益风险评估数据，并且授权仍然是有条件的，直到满足监管机构提出的确认性上市后措施为止。对于经过AA认证的产品，应提供完整的安全性和有效性数据，并且授权后的措施可能仅包括风险管理和药物警戒计划的标准要求。在支持通过快速途径评估产品的关键试验中，与等待预期的临床结果相比，替代终点减少了药物开发时间。尚未通过系统研究研究支持通过CMA和AA途径授权的产品的替代终点能否可靠地预测治疗的临床益处。我们的目标是确定使用替代端点的程度，并评估是否已根据发布的层次结构确认了其有效性。

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