A systematic review of guidelines for internal validity in the design, conduct and analysis of biomedical experiments involving laboratory animals

Jan Vollert, Esther Schenker, Malcolm Macleod, Anton Bespalov, Hanno Wuerbel, Martin C Michel, Ulrich Dirnagl, Heidrun Potschka, Ann-Marie Waldron, Kimberley E Wever, Thomas Steckler, Tom Van De Casteele, Bruce Altevogt, Annesha Sil, Andrew SC Rice

Research output: Contribution to journalLiterature review

Abstract

Over the last two decades, awareness of the negative repercussions of flaws in the planning, conduct and reporting of preclinical research involving experimental animals has been growing. Several initiatives have set out to increase transparency and internal validity of preclinical studies, mostly publishing expert consensus and experience. While many of the points raised in these various guidelines are identical or similar, they differ in detail and rigour. Most of them focus on reporting, only few of them cover the planning and conduct of studies. The aim of this systematic review is to identify existing experimental design, conduct, analysis and reporting guidelines relating to preclinical animal research. A systematic search in PubMed, Embase and Web of Science retrieved 13 863 unique results. After screening these on title and abstract, 613 papers entered the full-text assessment stage, from which 60 papers were retained. From these, we extracted unique 58 recommendations on the planning, conduct and reporting of preclinical animal studies. Sample size calculations, adequate statistical methods, concealed and randomised allocation of animals to treatment, blinded outcome assessment and recording of animal flow through the experiment were recommended in more than half of the publications. While we consider these recommendations to be valuable, there is a striking lack of experimental evidence on their importance and relative effect on experiments and effect sizes.

Original languageEnglish
Article numbere100046
Number of pages8
JournalBMJ Open Science
Volume4
Issue number1
Early online date15 Apr 2020
DOIs
Publication statusPublished - Apr 2020

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    Vollert, J., Schenker, E., Macleod, M., Bespalov, A., Wuerbel, H., Michel, M. C., Dirnagl, U., Potschka, H., Waldron, A-M., Wever, K. E., Steckler, T., Casteele, T. V. D., Altevogt, B., Sil, A., & SC Rice, A. (2020). A systematic review of guidelines for internal validity in the design, conduct and analysis of biomedical experiments involving laboratory animals. BMJ Open Science, 4(1), [e100046]. https://doi.org/10.1136/bmjos-2019-100046