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中国医药导刊 ›› 2024, Vol. 26 ›› Issue (2): 119-123.

• 专栏:药物临床试验 • 上一篇    下一篇

浅谈独立评审委员会(IRC)在创新药研发中的重要价值

孔亮1, 蔡鑫2, 孔维迈3*   

  1. 1.礼新医药科技(上海)有限公司, 上海 201203;
    2.浙江太美医疗科技股份有限公司,浙江 杭州 310000;
    3.蒙特维德学院,美国 佛罗里达州 34756
  • 收稿日期:2024-01-04 修回日期:2024-01-05 出版日期:2024-02-28 发布日期:2024-02-28

The Unique Value of Independent Review Committee IRC in Clinical Trials for Innovative Drugs

  1. 1.LaNova Medicines Ltd. Shanghai 201203, China
    2.Zhejiang Taimei Medical Technology Co. Ltd. Zhejiang Hangzhou 310000, China
    3.Montverde Academy Florida FL 34756, U.S.
  • Received:2024-01-04 Revised:2024-01-05 Online:2024-02-28 Published:2024-02-28

摘要:

在药物/医疗器械研发临床试验中,尤其是抗肿瘤药物临床试验中,主要终点有时需要由影像来进行评估。当临床试验采用影像相关终点作为主要研究终点时,为保障评估的客观性和稳定性,通常会在临床研究中设置独立评审委员会(Independent Review CommitteeIRC),即“独立影像评估”。IRC采用标准化影像评价程序,提供影像方案标准化、改善数据质量、减少偏倚和差异性以及为监管机构审批提供依据,在影像学临床试验中发挥重要作用。IRC适用范围主要包括安全性的评估、疗效/有效性的评估、影像学数据、病理学数据和照片数据。IRC可提高影像评估的客观性、可靠性,助力新药研发,为制药行业带来更多获益。本研究在梳理IRC发展历史的基础上,简述了国内外监管机构对IRC设置和运行的相关指导要求,分析了IRC对于药物/医疗器械研发的价值,总结了IRC的工作内容、适用场景和常用的评估标准,并对IRC未来的发展方向进行了展望,旨在为更多的新药研发提供经验和参考。


关键词: 独立评审委员会(IRC), 新药研发, 疗效评估, 临床试验

Abstract:

In clinical trials of drug/medical device research and development especially in clinical trials of anti-tumor drugs sometimes the main endpoints are evaluated by images. When image-related endpoints are used as the main study endpoint in clinical trials in order to ensure the objectivity and stability of the evaluation the Independent Review Committee IRC is usually set up in clinical research that is the "independent image evaluation". IRC uses standardized image evaluation procedures to provide image protocol standardization improve data quality reduce bias and variability and provide support for regulatory approval which plays an important role in clinical trials. The scope of IRC's application mainly includes safety evaluation efficacy/effectiveness evaluation imaging data pathological data and photo data. IRC can improve the objectivity and reliability of image evaluation help develope new drugs and thus bring more benefits to the pharmaceutical industry. On the basis of sorting out the history of IRC's development this study briefly describes the relevant guidance requirements of the regulatory agencies on setting and running IRC analyzes the value of IRC for the research and development of drugs/medical devices and summarizes the work content applicable scenarios and commonly used evaluation criterias of IRC and the future development trend of IRC with the aim to provide experience and reference for more new drug research and development.


Key words:  , Independent Review Committee , IRC); , New drug research and development , Evaluation of efficacy , Clinical trial

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