Everitt Jeffrey I, Treuting Piper M, Scudamore Cheryl, Sellers Rani, Turner Patricia V, Ward Jerrold M, Zeiss Caroline J
Duke University, Durham, North Carolina.
University of Washington, Seattle, WA.
ILAR J. 2018 Dec 1;59(1):4-12. doi: 10.1093/ilar/ily020.
In translational research, animal models are an important tool to aid in decision-making when taking potential therapies into human clinical trials. Recently, there have been a number of papers that have suggested limited concordance of preclinical animal experiments with subsequent human clinical experience. Assessments of preclinical animal studies have led to concerns about the reproducibility of data and have highlighted the need for an emphasis on rigor and quality in the planning, conduct, analysis, and reporting of such studies. The incorporation of a wider role for the comparative pathologist using pathology best practices in the planning and conduct of animal model-based research is one way to increase the quality and reproducibility of data. The use of optimal design and planning of tissue collection, incorporation of pathology methods into written protocols, conduct of pathology procedures using accepted best practices, and the use of optimal pathology analysis and reporting methods enhance the quality of the data acquired from many types of preclinical animal models and studies. Many of these pathology practices are well established in the discipline of toxicologic pathology and have a proven and useful track record in enhancing the data from animal-based studies used in safety assessment of human therapeutics. Some of this experience can be adopted by the wider community of preclinical investigators to increase the reproducibility of animal study data.
在转化研究中，动物模型是帮助将潜在疗法推进到人体临床试验时进行决策的重要工具。最近，有许多论文指出临床前动物实验与后续人体临床经验之间的一致性有限。对临床前动物研究的评估引发了对数据可重复性的担忧，并突出了在这类研究的规划、实施、分析和报告中强调严谨性和质量的必要性。在基于动物模型的研究的规划和实施中，让比较病理学家运用最佳病理实践发挥更广泛作用，是提高数据质量和可重复性的一种方法。采用最佳的组织收集设计和规划，将病理方法纳入书面方案，按照公认的最佳实践进行病理程序，以及使用最佳的病理分析和报告方法，可提高从多种临床前动物模型和研究中获取的数据质量。其中许多病理实践在毒理病理学领域已得到充分确立，并且在增强用于人类治疗药物安全性评估的动物研究数据方面有着经过验证且有用的记录。临床前研究人员群体中的其他人员可以借鉴其中一些经验，以提高动物研究数据的可重复性。
