Potter David, Bradstreet Thomas, Sargsyan Davit, Tan Xiao, Bonato Vinicius, Li Dingzhou, Liang John, Libiger Ondrej, Sendecki Jocelyn, Stansfield John, Tatikola Kanaka, Xu Jialin, Campbell Brandy
Nonclinical Statistics, R&D, Pfizer Inc, Cambridge, Massachusetts, USA.
Independent Statistical Mentor for Preclinical Scientists, Landsdale, Pennsylvania, USA.
Pharm Stat. 2025 Jan-Feb;24(1):e2390. doi: 10.1002/pst.2390. Epub 2024 Jun 11.
In this tutorial we explore the valuable partnership between statisticians and Institutional Animal Care and Use Committees (IACUCs) in the context of animal research, shedding light on the critical role statisticians play in ensuring the ethical and scientifically rigorous use of animals in research. Pharmaceutical statisticians have increasingly become vital members of these committees, contributing expertise in study design, data analysis, and interpretation, and working more generally to facilitate the integration of good statistical practices into experimental procedures. We review the "3Rs" principles (Replacement, Reduction, and Refinement) which are the foundation for the humane use of animals in scientific research, and how statisticians can partner with IACUC to help ensure robust and reproducible research while adhering to the 3Rs principles. We also highlight emerging areas of interest, such as the use of virtual control groups.
在本教程中，我们探讨了统计学家与机构动物护理和使用委员会（IACUC）在动物研究背景下的宝贵合作关系，揭示了统计学家在确保研究中动物的道德和科学严谨使用方面所发挥的关键作用。制药统计学家日益成为这些委员会的重要成员，在研究设计、数据分析和解释方面贡献专业知识，并更广泛地致力于促进将良好的统计实践融入实验程序。我们回顾了“3R”原则（替代、减少和优化），这是科学研究中人道使用动物的基础，以及统计学家如何与IACUC合作，在坚持“3R”原则的同时，帮助确保研究的稳健性和可重复性。我们还强调了新兴的关注领域，例如虚拟对照组的使用。
