首页|加强国际动物实验注册平台建设——基于注册计划书的系统调查

加强国际动物实验注册平台建设——基于注册计划书的系统调查

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目的 详细分析国际动物实验注册平台研究计划书的流行病学特征,为动物实验注册的建设和完善提出有益建议.方法 获取荷兰PCT和德国ASR动物实验注册平台截至2023年12月30日注册的动物实验原始计划书并提取信息,采取频数及构成百分比统计描述数据.结果 共纳入272篇注册计划书,其中PCT平台124篇,ASR平台148篇,来自于31个国家,涉及47个不同的研究领域,共包含11种不同动物;实验设计方法,仍有10.0%(27/272)的研究未提及随机分组,而且即使进行了随机分组的实验(132/272)均未提及隐蔽分组;24.6%(67/272)和35.3%(96/272)的研究未报告干预实施阶段和结局指标测量阶段的盲法应用情况;仅43.3%(97/224)实验在计划书规定时间内完成.结论 动物实验的注册作为提高动物实验质量的重要措施,应该得到重视和推广,注册平台与研究者应合作优化注册平台机制,提高计划书质量,增强实验透明度,共同提高动物实验的质量,为动物实验的临床转化提供更可靠的基础.
Construction of international animal experiment registration platforms needs improvement:A systematic survey based on registration protocols
Objective To analyze in detail the epidemiological characteristics of research proposals on the International Animal Experiment Registration Platform,and to make useful suggestions for the construction and improvement of animal experiment registration.Methods Original protocols for animal experiments registered on the Dutch PCT and German ASR animal experiment registration platforms as of December 30,2023 were included and information extracted,and frequency counts and composition percentages taken to statistically describe the data.Results A total of 272 registration proposals were included,of which 124 were from the PCT platform and 148 from the ASR platform,from 31 countries,covering 47 different research areas and containing a total of 11 different animals;in terms of experimental design methodology,10%(27/272)of the studies did not yet mention randomized grouping and,even in the experiments where randomized grouping was carried out(132/272),none of the experiments mentioned concealed grouping.24.6%(67/272)and 35.3%(96/272)of the studies did not report on the application of blinding during the intervention implementation phase and the measurement of outcome indicators.In addition,only 43.3%(97/224)of the experiments were completed within the planned expected completion time.Conclusion The registration of animal experiments,as an important measure to improve the quality of animal experiments,should be valued and promoted.Registration platforms and researchers should cooperate to optimize the mechanism of registra tion platforms,improve the quality of plans,enhance the transparency of experiments,and work together to improve the quality of animal experiments and provide a more reliable basis for the clinical translation of animal experiments.

animal experimentationanimal experimentation registrationanimal experimentation translationregistration platformsregistration protocol

易少威、王陆军、阮建华、王浙、丁奉兴、奥琪、任紫钰、刘晏利、吴才志、罗雅婷、牛牧町、赵跃、李朝霞、马彬

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兰州大学 基础医学院,甘肃 兰州 730000

甘肃省妇幼保健院 新生儿重症救护中心,甘肃 兰州 730050

甘肃中医药大学 公共卫生学院,甘肃 兰州 730000

甘肃省第二人民医院 科研和研究生科,甘肃 兰州 730000

西北民族大学 临床医学院,甘肃 兰州 730000

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动物实验 动物实验注册 动物实验转化 注册平台 注册计划书

2024

兰州大学学报(医学版)
兰州大学

兰州大学学报(医学版)

CSTPCD
影响因子:0.641
ISSN:1000-2812
年,卷(期):2024.50(8)