摘要
目的 分析美国食品药品监督管理局(FDA)临床试验暂停机制,为我国临床试验审评改革创新提供借鉴与启示。方法 通过对美国临床试验暂停相关的法律规定、实施程序、暂停的原因及影响进行分析,对比我国临床试验管理制度,提出我国临床试验管理的改革建议。结果与结论 美国FDA对临床试验实施30 d默示许可程序,可以使临床试验尽早开始,对临床试验过程实行暂停、恢复与终止的动态监管,最大限度地保护受试者的健康和权益,同时提高审评效率。我国药物临床试验引入暂停程序是必要的和可行的。
Abstract
OBJECTIVE To analyze the mechanism of clinical hold in USA and to provide reference and enlightenment for clinical trial review process reform in China. METHODS Analyzed the regulation, review process, reasons and impacts of drug clinical hold in USA and compared with clinical trial system in China, then provided advice for our country. RESULTS AND CONCLUSION FDA review IND by implied license process within only 30 d, and may permit the clinical trials begin as early as possible, the clinical trial could be imposed on hold, and the hold could also be lifted or transfer into inactive status, thus protect the health and rights of subjects to the largest extent, and in the same time improved the review efficiency. It is necessary and feasible that clinical hold is introduced into clinical trial system in our country.
关键词
新药临床试验 /
新药临床试验申请 /
暂停机制
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Key words
investigational new drug application /
IND /
clinical hold
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袁丽, 杨悦.
美国药物临床试验暂停机制研究[J]. 中国药学杂志, 2017, 52(9): 787-792 https://doi.org/10.11669/cpj.2017.09.017
YUAN Li, YANG Yue.
Research on Mechanism of Drug Clinical Hold in USA[J]. Chinese Pharmaceutical Journal, 2017, 52(9): 787-792 https://doi.org/10.11669/cpj.2017.09.017
中图分类号：
R951
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参考文献
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脚注
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基金
国家食品药品监督管理总局委托课题“药物临床试验管理法律制度研究”资助项目(20160003)
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