Department of Anesthesiology, University of Florida College of Medicine, Gainesville, USA.
Department of Small Animal Clinical Sciences, University of Florida College of Veterinary Medicine, Gainesville, USA.
Lab Anim. 2024 Oct;58(5):404-410. doi: 10.1177/00236772241276806.
Statistically based experimental designs have been available for over a century. However, many preclinical researchers are completely unaware of these methods, and the success of experiments is usually equated only with ' < 0.05'. By contrast, a well-thought-out experimental design strategy provides data with evidentiary and scientific value. A value-based strategy requires implementation of statistical design principles coupled with basic project management techniques. This article outlines the three phases of a value-based design strategy: proper framing of the research question, statistically based operationalisation through careful selection and structuring of appropriate inputs, and incorporation of methods that minimise bias and process variation. Appropriate study design increases study validity and the evidentiary strength of the results, reduces animal numbers, and reduces waste from noninformative experiments. Statistically based experimental design is thus a key component of the 'Reduction' pillar of the 3R (Replacement, Reduction, Refinement) principles for ethical animal research.
基于统计学的实验设计已经存在了一个多世纪。然而，许多临床前研究人员对此类方法完全不了解，并且实验的成功通常仅等同于“ < 0.05”。相比之下，精心设计的实验设计策略可提供具有证据和科学价值的数据。基于价值的策略需要实施统计设计原则，并结合基本项目管理技术。本文概述了基于价值的设计策略的三个阶段：正确提出研究问题，通过仔细选择和构建适当的输入进行基于统计学的操作，以及采用可最小化偏差和过程变异的方法。适当的研究设计可提高研究的有效性和结果的证据强度，减少动物数量，并减少非信息性实验的浪费。因此，基于统计学的实验设计是伦理动物研究的 3R（替代、减少、优化）原则的“减少”支柱的关键组成部分。
