实验动物与比较医学 ›› 2023, Vol. 43 ›› Issue (2): 213-224.DOI: 10.12300/j.issn.1674-5817.2023.043

所属专题: 动物实验设计及统计学方法

• 比较医学研究与报告规范 • 上一篇    下一篇

《动物研究:体内实验报告》即ARRIVE 2.0指南的解释和阐述(一)

王剑1(), 卢今1, 马政文1, 陈国元2, 卢晓3, 白玉4, 刘晓宇5, 卢选成6, 高静7, 李垚1, 庞万勇8()()   

  1. 1.上海交通大学医学院实验动物科学部, 上海 200025
    2.中国科学院分子细胞科学卓越创新中心动物实验技术平台, 上海 200031
    3.迪哲医药股份有限公司, 上海 201203
    4.北京诺和诺德医药科技有限公司, 北京 102206
    5.中国疾病预防控制中心职业卫生与中毒控制所, 北京 100050
    6.中国疾病预防控制中心实验动物中心, 北京 102206
    7.上海交通大学医学院临床研究中心, 上海 200025
    8.赛诺菲公司全球研发中心转化体内模型研究平台, 北京 100022
  • 收稿日期:2023-03-30 修回日期:2023-04-20 出版日期:2023-04-25 发布日期:2023-05-16
  • 通讯作者: 庞万勇(1974—),男,兽医学博士,研究方向:实验动物医学。E-mail: pang1yong@outlook.com。ORCID:0000-0002-0724-2016
  • 作者简介:王 剑(1986—),男,兽医学博士,实验师,研究方向:实验动物医学。E-mail: wangjian3976@shsmu.edu.cn

Explanation and Elaboration for the ARRIVE Guidelines 2.0—Reporting Animal Research and In Vivo Experiments (Ⅰ)

Jian WANG1(), Jin LU1, Zhengwen MA1, Guoyuan CHEN2, Xiao LU3, Yu BAI4, Xiaoyu LIU5, Xuancheng LU6, Jing GAO7, Yao LI1, Wanyong Pang8()()   

  1. 1.Department of Laboratory Animal Science, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China
    2.Animal Core Facility, Center for Excellence in Molecular Cell Science, Chinese Academy of Science, Shanghai 200031, China
    3.Dizal Pharmaceuticals Co. , Ltd. , Shanghai 201203, China
    4.Novo Nordisk Research Centre China, Beijing 102206, China
    5.National Institute for Occupational Health and Poison Control, Chinese Center for Disease Control and Prevention, Beijing 100050, China
    6.Laboratory Animal Center, Chinese Center for Disease Control and Prevention, Beijing 102206, China
    7.Clinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
    8.Translational in Vivo Model Research Platform, Sanofi G&D, Beijing 100022, China
  • Received:2023-03-30 Revised:2023-04-20 Published:2023-04-25 Online:2023-05-16
  • Contact: PANG Wanyong (ORCID: 0000-0002-0724-2016), E-mail: pang1yong@outlook.com

摘要:

提高生物医学研究结果的可重复性是一项重大挑战,研究人员透明且准确地报告其研究过程有利于读者对该研究结果的可靠性进行评估,进而重复该实验或在该成果的基础上进一步探索。ARRIVE 2.0指南是2019年英国国家3Rs中心(NC3Rs)组织发布的一份适用于任何与活体动物研究报告相关的指导性清单,用以提高动物体内实验设计、实验实施和实验报告的规范性,以及动物实验结果的可靠性、可重复性和临床转化率。ARRIVE 2.0指南的使用不仅可以丰富动物实验研究报告的细节,确保动物实验结果信息被充分评估和利用,还可以使读者准确且清晰地了解作者所表述的内容,促进基础研究评审过程的透明化和完整性。目前,ARRIVE 2.0指南已经被国际生物医学期刊广泛采纳。本文是在国际期刊遵循ARRIVE 2.0指南的最佳实践基础上,对2020年发表于PLoS Biology期刊上的ARRIVE 2.0指南完整解读版(原文请见https://arriveguidelines.org)进行中文编译(第一部分包括前言和“关键10条”里的“研究设计”“样本量”“纳入和排除标准”),以期促进国内研究人员充分理解并使用ARRIVE 2.0指南,提高实验动物研究及报告的规范性,助推我国实验动物科技与比较医学研究的高质量发展。

关键词: 动物实验, ARRIVE 2.0指南, ARRIVE关键10条, 研究设计, 样本量, 纳入和排除标准

Abstract:

Improving the reproducibility of biomedical research results is a major challenge. Researchers reporting their research process transparently and accurately can help readers evaluate the reliability of the research results and further explore the experiment by repeating it or building upon its findings. The ARRIVE 2.0 guidelines, released in 2019 by the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), provide a checklist applicable to any in vivo animal research report. These guidelines aim to improve the standardization of experimental design, implementation, and reporting, as well as the reliability, repeatability, and clinical translatability of animal experimental results. The use of ARRIVE 2.0 guidelines not only enriches the details of animal experimental research reports, ensuring that information on animal experimental results is fully evaluated and utilized, but also enables readers to understand the content expressed by the author accurately and clearly, promoting the transparency and integrity of the fundamental research review process. At present, the ARRIVE 2.0 guidelines have been widely adopted by international biomedical journals. this article is a Chinese translation based on the best practices of international journals following the ARRIVE 2.0 guidelines in international journals, specifically for the complete interpretation of the ARRIVE 2.0 guidelines published in the PLoS Biology journal in 2020 (original text can be found at https://arriveguidelines.org). The first part of the article includes the preface and the "Key 10" section, which covers "study design" "sample size" and "inclusion and exclusion criteria". Its aim is to promote the full understanding and use of the ARRIVE 2.0 guidelines by domestic researchers, enhance the standardization of experimental animal research and reporting, and promote the high-quality development of experimental animal technology and comparative medicine research in China.

Key words: Animal experiment, ARRIVE 2.0 guidelines, ARRIVE essential 10, Study design, Sample size, Inclusion and exclusion criteria

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