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Testing the limits: can enhanced external validity promote translation?

作者信息

MacLellan Aileen, Lalu Manoj M

机构信息

Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada; Canadian Council on Animal Care, Ottawa, Ontario, Canada.

Blueprint Translational Research Group, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Cellular and Molecular Medicine, University of Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada; Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.

出版信息

EBioMedicine. 2024 Dec;110:105473. doi: 10.1016/j.ebiom.2024.105473. Epub 2024 Nov 26.

DOI:10.1016/j.ebiom.2024.105473
PMID:39603137
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11629222/
Abstract
摘要

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本文引用的文献

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EBioMedicine. 2024 Dec;110:105434. doi: 10.1016/j.ebiom.2024.105434. Epub 2024 Nov 7.
2
Analysis of animal-to-human translation shows that only 5% of animal-tested therapeutic interventions obtain regulatory approval for human applications.动物到人体转化的分析表明，只有5%经过动物试验的治疗性干预措施获得了用于人体的监管批准。
PLoS Biol. 2024 Jun 13;22(6):e3002667. doi: 10.1371/journal.pbio.3002667. eCollection 2024 Jun.
3
A systematic assessment of preclinical multilaboratory studies and a comparison to single laboratory studies.系统评估临床前多实验室研究并与单实验室研究进行比较。
Elife. 2023 Mar 9;12:e76300. doi: 10.7554/eLife.76300.
4
Embracing Heterogeneity in The Multicenter Stroke Preclinical Assessment Network (SPAN) Trial.拥抱多中心卒中临床前评估网络（SPAN）试验中的异质性。
Stroke. 2023 Feb;54(2):620-631. doi: 10.1161/STROKEAHA.122.040638. Epub 2023 Jan 5.
5
The standardization fallacy.标准化谬误。
Nat Methods. 2021 Jan;18(1):5-7. doi: 10.1038/s41592-020-01036-9.
6
The ARRIVE guidelines 2.0: Updated guidelines for reporting animal research.ARRIVE 指南 2.0：报告动物研究的更新指南。
PLoS Biol. 2020 Jul 14;18(7):e3000410. doi: 10.1371/journal.pbio.3000410. eCollection 2020 Jul.
7
Innovation in the pharmaceutical industry: New estimates of R&D costs.制药行业的创新：研发成本的新估计
J Health Econ. 2016 May;47:20-33. doi: 10.1016/j.jhealeco.2016.01.012. Epub 2016 Feb 12.
8
Late, never or non-existent: the inaccessibility of preclinical evidence for new drugs.滞后、缺失或根本不存在：新药临床前证据难以获取的情况。
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9
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Stroke. 2008 Oct;39(10):2824-9. doi: 10.1161/STROKEAHA.108.515957. Epub 2008 Jul 17.
10
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Am J Med. 2003 Apr 15;114(6):477-84. doi: 10.1016/s0002-9343(03)00013-5.