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成功加速学术医学中心的转化研究:密歇根大学-库尔特转化研究伙伴计划。

Successfully accelerating translational research at an academic medical center: the University of Michigan-Coulter translational research partnership program.

机构信息

The Michigan Institute for Clinical Research, the University of Michigan, Ann Arbor, Michigan, USA.

出版信息

Clin Transl Sci. 2010 Dec;3(6):316-8. doi: 10.1111/j.1752-8062.2010.00248.x.

Abstract

Translational research encompasses the effective movement of new knowledge and discoveries into new approaches for prevention, diagnosis, and treatment of disease. There are many roadblocks to successful bench to bedside research, but few have received as much recent attention as the "valley of death". The valley of death refers to the lack of funding and support for research that moves basic science discoveries into diagnostics, devices, and treatments in humans, and is ascribed to be the result of companies unwilling to fund research development that may not result in a drug or device that will be utilized in the clinic and conversely, the fact that researchers have no access to the funding needed to carry out preclinical and early clinical development to demonstrate potential efficacy in humans. The valley of death also exists because bridging the translational gap is dependent on successfully managing an additional four risks: scientific, intellectual property, market, and regulatory. The University of Michigan (UM) has partnered with the Wallace H. Coulter Foundation (CF) to create a model providing an infrastructure to overcome these risks. This model is easily adoptable to other academic medical centers (AMCs).

摘要

转化研究包括将新知识和发现有效地应用于疾病的预防、诊断和治疗新方法中。成功的基础研究到临床研究存在许多障碍,但很少有像“死亡之谷”这样受到如此多关注的障碍。“死亡之谷”是指缺乏资金和支持,无法将基础科学发现转化为人类的诊断、设备和治疗方法,这被归因于公司不愿意为可能不会产生将在临床上使用的药物或设备的研究开发提供资金,相反,研究人员也无法获得开展临床前和早期临床开发所需的资金,以证明在人类身上的潜在疗效。“死亡之谷”的存在还因为跨越转化差距取决于成功管理另外四个风险:科学、知识产权、市场和监管。密歇根大学(UM)与华莱士 H. 库尔特基金会(CF)合作,创建了一个提供基础设施以克服这些风险的模型。该模型易于被其他学术医疗中心(AMC)采用。

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