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From the Cover: Contribution of NIH funding to new drug approvals 2010–2016

机译:从封面开始:2010-2016年NIH资金对新药批准的贡献

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摘要

This work examines the contribution of NIH funding to published research associated with 210 new molecular entities (NMEs) approved by the Food and Drug Administration from 2010–2016. We identified >2 million publications in PubMed related to the 210 NMEs (n = 131,092) or their 151 known biological targets (n = 1,966,281). Of these, >600,000 (29%) were associated with NIH-funded projects in RePORTER. This funding included >200,000 fiscal years of NIH project support (1985–2016) and project costs >$100 billion (2000–2016), representing ∼20% of the NIH budget over this period. NIH funding contributed to every one of the NMEs approved from 2010–2016 and was focused primarily on the drug targets rather than on the NMEs themselves. There were 84 first-in-class products approved in this interval, associated with >$64 billion of NIH-funded projects. The percentage of fiscal years of project funding identified through target searches, but not drug searches, was greater for NMEs discovered through targeted screening than through phenotypic methods (95% versus 82%). For targeted NMEs, funding related to targets preceded funding related to the NMEs, consistent with the expectation that basic research provides validated targets for targeted screening. This analysis, which captures basic research on biological targets as well as applied research on NMEs, suggests that the NIH contribution to research associated with new drug approvals is greater than previously appreciated and highlights the risk of reducing federal funding for basic biomedical research.
机译:这项工作研究了美国国立卫生研究院(NIH)资助对已发表的与210-2010年由美国食品药品管理局(FDA)批准的210个新分子实体(NME)相关的研究的贡献。我们在PubMed中确定了超过200万种出版物,涉及210种NME(n = 131,092)或它们的151种已知生物学靶标(n = 1,966,281)。其中,> 600,000(29%)与NIH在REPORTER中资助的项目有关。这笔资金包括超过20万个财政年度的NIH项目支持(1985-2016年)和项目成本超过1000亿美元(2000-2016年),约占NIH在此期间预算的20%。 NIH的资金为2010-2016年批准的每一个NME做出了贡献,并且主要集中在药物目标上,而不是NME本身。在此期间,批准了84项一流产品,与NIH资助的项目> 640亿美元相关。通过目标搜索而非药物搜索确定的项目资金的财政年度百分比比通过表型方法发现的通过目标筛选发现的NME更大(95%比82%)。对于目标NME,与目标相关的资金先于与NME相关的资金,这与对基础研究为目标筛选提供经过验证的目标的期望相一致。这项分析涵盖了生物学目标的基础研究以及NME的应用研究,表明NIH对与新药批准相关的研究的贡献比以前认可的要大,并突出显示了减少联邦对基础生物医学研究的资助的风险。

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