Over the last two decades, awareness of the negative repercussions of flaws in the planning, conduct and reporting of preclinical research involving experimental animals has been growing. Several initiatives have set out to increase transparency and internal validity of preclinical studies, mostly publishing expert consensus and experience. While many of the points raised in these various guidelines are identical or similar, they differ in detail and rigour. Most of them focus on reporting, only few of them cover the planning and conduct of studies. The aim of this systematic review is to identify existing experimental design, conduct, analysis and reporting guidelines relating to preclinical animal research. A systematic search in PubMed, Embase and Web of Science retrieved 13 863 unique results. After screening these on title and abstract, 613 papers entered the full-text assessment stage, from which 60 papers were retained. From these, we extracted unique 58 recommendations on the planning, conduct and reporting of preclinical animal studies. Sample size calculations, adequate statistical methods, concealed and randomised allocation of animals to treatment, blinded outcome assessment and recording of animal flow through the experiment were recommended in more than half of the publications. While we consider these recommendations to be valuable, there is a striking lack of experimental evidence on their importance and relative effect on experiments and effect sizes.

中文翻译：

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对涉及实验动物的临床前生物医学实验的设计、实施和分析的内部有效性指南进行系统审查


在过去的二十年里，人们越来越意识到涉及实验动物的临床前研究的规划、实施和报告中的缺陷所带来的负面影响。多项举措旨在提高临床前研究的透明度和内部有效性，主要发布专家共识和经验。虽然这些不同的指导方针中提出的许多观点是相同或相似的，但它们在细节和严格性上有所不同。其中大多数侧重于报告，只有少数涉及研究的规划和实施。本系统评价的目的是确定与临床前动物研究相关的现有实验设计、实施、分析和报告指南。在 PubMed、Embase 和 Web of Science 中进行的系统检索检索到了 13 863 个独特结果。经过标题和摘要筛选，共有613篇论文进入全文评审阶段，最终保留60篇论文。我们从中提取了 58 条关于临床前动物研究的规划、实施和报告的独特建议。超过一半的出版物推荐了样本量计算、适当的统计方法、隐藏和随机分配动物进行治疗、盲法结果评估和记录实验中的动物流程。虽然我们认为这些建议很有价值，但关于它们的重要性以及对实验和效应大小的相对影响却明显缺乏实验证据。