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重现性问题与临床前学术药物研发:促进转化成功的教育与机构举措。

The reproducibility issue and preclinical academic drug discovery: educational and institutional initiatives fostering translation success.

机构信息

a Center for Drug Discovery , Northeastern University , Boston , MA , USA.

b Department of Pharmaceutical Sciences and Health Sciences Entrepreneurs, Bouvé College of Health Sciences , Northeastern University , Boston , MA , USA.

出版信息

Expert Opin Drug Discov. 2016 Sep;11(9):835-42. doi: 10.1080/17460441.2016.1212014. Epub 2016 Jul 25.


DOI:10.1080/17460441.2016.1212014
PMID:27401809
Abstract

INTRODUCTION: Drug discovery depends critically upon published results from the academy. The reproducibility of preclinical research findings reported by academia in the peer-reviewed literature has been called into question, seriously jeopardizing the value of academic science for inventing therapeutics. AREAS COVERED: The corrosive effects of the reproducibility issue on drug discovery are considered. Purported correctives imposed upon academia from the outside deal mainly with expunging fraudulent literature and imposing punitive sanctions on the responsible authors. The salutary influence of such post facto actions on the reproducibility of discovery-relevant preclinical research data from academia appears limited. Rather, intentional doctoral-scientist education focused on data replicability and translationally-meaningful science and active participation of university entities charged with research innovation and asset commercialization toward ensuring data quality are advocated as key academic initiatives for addressing the reproducibility issue. EXPERT OPINION: A mindset shift on the part of both senior university faculty and the academy to take responsibility for the data reproducibility crisis and commit proactively to positive educational, incentivization, and risk- and reward-sharing practices will be fundamental for improving the value of published preclinical academic research to drug discovery.

摘要

简介:药物研发严重依赖学术界发表的研究成果。学术界在同行评议文献中报告的临床前研究结果的可重复性受到质疑,严重危及学术科学在发明治疗方法方面的价值。

涵盖领域:考虑了可重复性问题对药物发现的腐蚀性影响。据称,外部对学术界施加的纠正措施主要涉及清除虚假文献,并对负责的作者实施惩罚性制裁。此类事后行动对提高学术领域与发现相关的临床前研究数据的可重复性的有益影响似乎有限。相反,倡导专注于数据可重复性和具有转化意义的科学的博士生科学家教育,以及积极参与负责研究创新和资产商业化的大学实体,以确保数据质量,是解决可重复性问题的关键学术举措。

专家意见:资深大学教职员工和学术界需要转变观念,对数据可重复性危机负责,并积极采取积极的教育、激励措施,以及风险和收益共享措施,这对于提高已发表的临床前学术研究对药物发现的价值至关重要。

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