Pathology Study Design, Conduct, and Reporting to Achieve Rigor and Reproducibility in Translational Research Using Animal Models.

Autor:	Everitt JI; Duke University, Durham, North Carolina., Treuting PM; University of Washington, Seattle, WA., Scudamore C; Envigo CRS Ltd, Huntingdon, UK., Sellers R; Pfizer Inc., Pearl River, New York., Turner PV; Department of Pathobiology, University of Guelph, Guelph, ON, Canada., Ward JM; Global VetPathology, Montgomery Village, MD., Zeiss CJ; Department of Comparative Medicine, Yale University School of Medicine, New Haven, Connecticut.
Jazyk:	angličtina
Zdroj:	ILAR journal [ILAR J] 2018 Dec 01; Vol. 59 (1), pp. 4-12.
DOI:	10.1093/ilar/ily020
Abstrakt:	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. (© The Author(s) 2019. Published by Oxford University Press on behalf of the National Academy of Sciences. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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