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Harman, N.L.* ; Sanz-Moreno, A. ; Papoutsopoulou, S.* ; Lloyd, K.A.* ; Ameen-Ali, K.E.* ; MacLeod, M.* ; Williamson, P.R.*

Can harmonisation of outcomes bridge the translation gap for pre-clinical research? A systematic review of outcomes measured in mouse models of type 2 diabetes.

J. Transl. Med. 18:468 (2020)
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Open Access Gold
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In pre-clinical research, systematic reviews have the potential to mitigate translational challenges by facilitating understanding of how pre-clinical studies can inform future clinical research. Yet their conduct is encumbered by heterogeneity in the outcomes measured and reported, and those outcomes may not always relate to the most clinically important outcomes. We aimed to systematically review outcomes measured and reported in pre-clinical in vivo studies of pharmacological interventions to treat high blood glucose in mouse models of type 2 diabetes.


A systematic review of pre-clinical in vivo studies of pharmacological interventions aimed at addressing elevated blood glucose in mouse models of type 2 diabetes was completed. Studies were screened for eligibility and outcomes extracted from the included studies. The outcomes were recorded verbatim and classified into outcome domains using an existing outcome taxonomy. Outcomes were also compared to those identified in a systematic review of registered phase 3/4 clinical trials for glucose lowering interventions in people with type 2 diabetes.


Review of 280 included studies identified 532 unique outcomes across 19 domains. No single outcome, or domain, was measured in all studies and only 132 (21%) had also been measured in registered phase 3/4 clinical trials. A core outcome set, representing the minimum that should be measured and reported, developed for type 2 diabetes effectiveness clinical trials includes 18 core outcomes, of these 12 (71%) outcomes were measured and reported in one or more of the included pre-clinical studies.


There is heterogeneity of outcomes reported in pre-clinical research. Harmonisation of outcomes across the research pathway using a core outcome set may facilitate interpretation, evidence synthesis and translational success, and may contribute to the refinement of the use of animals in research.

Systematic review registration: The study was prospectively registered on the PROSPERO Database, registration number CRD42018106831

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Publication type Article: Journal article
Document type Scientific Article
Keywords Type 2 Diabetes ; Pre-clinical Research ; Mouse Models Of Type 2 Diabetes ; Core Outcome Set ; Translational Research ; Clinical Research ; Pre-clinical Systematic Review; Animal Research
ISSN (print) / ISBN 1479-5876
e-ISSN 1479-5876
Quellenangaben Volume: 18, Issue: 1, Pages: , Article Number: 468 Supplement: ,
Publisher BioMed Central
Publishing Place Campus, 4 Crinan St, London N1 9xw, England
Reviewing status Peer reviewed
Grants European Union’s Horizon 2020 research and innovation programme