支持 FDA 批准突破性治疗指定药物的临床试验证据。
Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation.
机构信息
Yale School of Medicine, New Haven, Connecticut.
Collaboration for Research Integrity and Transparency, Yale University, New Haven, Connecticut.
出版信息
JAMA. 2018 Jul 17;320(3):301-303. doi: 10.1001/jama.2018.7619.
Abstract
This study used the Drugs@FDA database to review FDA-approved “breakthrough” therapies from 2012 to 2017 (characterizing the pivotal clinical trials that serve as the basis of FDA approval), and premarket development and review times to assess the strength of evidence supporting breakthrough approvals.
摘要
本研究使用 Drugs@FDA 数据库，回顾了 2012 年至 2017 年获得 FDA 批准的“突破性”疗法（定义为作为 FDA 批准基础的关键临床试验），以及上市前的开发和审查时间，以评估支持突破性批准的证据强度。
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