Townsend Hugh G G, Osterrieder Klaus, Jelinski Murray D, Morck Douglas W, Waldner Cheryl L, Cox William R, Gerdts Volker, Potter Andrew A, Babiuk Lorne A, Cross James C
Department of Large Animal Clinical Sciences, Western College of Veterinary Medicine (Emeritus) and Vaccine and Infectious Disease Organization (Retired), University of Saskatchewan, Saskatoon, SK, Canada.
University of Veterinary Medicine Hannover, Foundation, Hannover, Germany.
Sci Rep. 2025 Aug 21;15(1):30745. doi: 10.1038/s41598-025-15935-4.
During the design of hypothesis-driven, comparative laboratory animal experiments, investigators must control for cage effects, ensure full blinding and full randomization while adhering to established experimental designs, notably variations of the Completely Randomized Design and the Randomized Block Designs. Failure to meet these criteria introduces partial or complete confounding by multiple known and unknown variables, resulting in biased outcome measures and rendering valid statistical analysis impossible. Our analysis of a stratified, random sample of comparative laboratory animal experiments conducted in North America and Europe and published in 2022, shows that as few as 0-2.5% utilized valid, unbiased experimental designs. The failure of investigators to adopt valid, unbiased study designs undermines scientific rigour, squanders resources and animal lives, and impedes the reliable translation of preclinical research findings to human and veterinary medicine. We propose practical, achievable solutions focused on enhancing the rigour and validity of study designs. This includes developing a specialized group of scientists with expertise in the design of laboratory animal experiments and data analysis, to ensure future studies are conducted with the highest scientific standards.
在设计假设驱动的比较性实验动物实验时，研究人员必须控制笼养效应，确保完全盲法和完全随机化，同时遵循既定的实验设计，特别是完全随机设计和随机区组设计的变体。未能满足这些标准会导致多个已知和未知变量造成部分或完全混杂，从而产生有偏差的结果测量，并使有效的统计分析变得不可能。我们对2022年在北美和欧洲进行并发表的比较性实验动物实验的分层随机样本进行的分析表明，只有0-2.5%的实验采用了有效、无偏的实验设计。研究人员未能采用有效、无偏的研究设计，破坏了科学严谨性，浪费了资源和动物生命，并阻碍了临床前研究结果向人类和兽医学的可靠转化。我们提出了注重提高研究设计严谨性和有效性的切实可行的解决方案。这包括培养一批在实验动物实验设计和数据分析方面具有专业知识的科学家，以确保未来的研究以最高的科学标准进行。
