Everitt Jeffrey I
GlaxoSmithKline, Research Triangle Park, North Carolina, USA
Toxicol Pathol. 2015 Jan;43(1):70-7. doi: 10.1177/0192623314555162. Epub 2014 Oct 27.
Animal models have provided an important tool to help make the decision to take potential therapies from preclinical studies to humans. In the past several years, the strong reliance of the pharmaceutical discovery and development process on the use of animal models has come under increasing scrutiny for ethical and scientific reasons. Several prominent and widely publicized articles have reported limited concordance of animal experiments with subsequent human clinical trials. Recent assessments of the quality of animal studies have suggested that this translational failure may be due in part to shortcomings in the planning, conduct, and reporting of in vivo studies. This article will emphasize methods to assure best practice rigor in animal study methods and reporting. It will introduce the so-called scientific 3Rs of relevance, robustness, and reproducibility to the in vivo study approach and will review important new trends in the animal research and pharmaceutical discovery and development communities.
动物模型为帮助做出将潜在疗法从临床前研究应用于人类的决策提供了重要工具。在过去几年中，由于伦理和科学原因，药物研发过程对动物模型使用的强烈依赖受到了越来越多的审视。几篇著名且广泛传播的文章报道了动物实验与后续人体临床试验之间的一致性有限。最近对动物研究质量的评估表明，这种转化失败可能部分归因于体内研究在规划、实施和报告方面的不足。本文将强调确保动物研究方法和报告达到最佳实践严谨性的方法。它将把所谓的相关性、稳健性和可重复性这三个科学原则引入体内研究方法，并将回顾动物研究以及药物研发领域的重要新趋势。
