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中国临床药理学与治疗学 ›› 2020, Vol. 25 ›› Issue (5): 591-594.doi: 10.12092/j.issn.1009-2501.2020.05.017

• 综述与讲座 • 上一篇    下一篇

后新冠肺炎疫情下临床试验的发展及思考

黄志军1,2,3, 阳国平1,2,3   

  1. 1中南大学湘雅三医院临床试验研究中心, 长沙 410013, 湖南;
    2中南大学湘雅三医院临床药理中心, 长沙 410013, 湖南;
    3药物临床评价技术国家地方联合工程实验室, 长沙 410013, 湖南
  • 发布日期:2020-07-06
  • 通讯作者: 黄志军,通信作者,男,博士,副研究员,博士生导师,主要从事临床药理学研究。Tel: 0731-88618339 E-mail: huangzj@csu.edu.cn
  • 作者简介:阳国平,男,博士,教授,博士生导师,主要从事临床药理学研究。Tel: 0731-88618933 E-mail: ygp9880@163.com
  • 基金资助:
    重大新药创制重大专项(2020ZX09201010);中南大学新型冠状病毒感染肺炎防控应急项目(502701001)

Clinical trials during post-COVID pandemic: An interim review

HUANG Zhijun1,2,3, YANG Guoping1,2,3   

  1. 1Research Center for Clinical Trial, the Third Xiangya Hospital, Central South University;
    2Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University;
    3National and Local Joint Engineering Laboratory for Drug Clinical Evaluation Technology, Changsha 410013, Hunan, China
  • Published:2020-07-06

摘要: 2020年,我国经历了前所未有的新型冠状病毒肺炎疫情。在重大公共卫生事件背景下,各地临床试验都经历了入组暂停、方案违背等一系列困难时期。随着全国复产复工,进入后新冠肺炎疫情时期。本文分析了临床试验机构如何恢复业务,倡导强化以受试者为中心设计临床试验流程、全面普及信息化、建设专业化的临床研究中心和临床研究支撑团队、中药拓展新用途尊重循证证据和真实世界证据、优化伦理委员会的审查模式、机构灾难恢复计划成为常态等疫情期间的应对措施和经验,并应用到将来的临床研究中。

关键词: 新型冠状病毒肺炎, 疫情, 临床试验

Abstract: China has experienced an unprecedented pandemic of corona virus disease 2019 (COVID-19) in 2020. In the background of serious public health events, clinical trials in most Chinese regions have experienced a series of tough periods such as suspension of admission and protocol violation. With resumption of work and production around the country, China has entered the post-COVID pandemic period. This article analyzes how clinical trial institutions resume professional work, and advocates to continue to strengthen the countermeasures and experience during the outbreak, such as the design of subject-centered clinical trial, comprehensively promotion of information technology, construction of professional clinical research centers and clinical research support teams, respecting evidence-based evidence and real-world evidence, optimal ethical committee review modes, and standardization of agency disaster recovery plan. These experiences should be applied to future clinical researches.

Key words: corona virus disease 2019, pandemic, clinical trial

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