Contribution of NIH funding to new drug approvals 2010-2016.

Contribution of NIH funding to new drug approvals 2010-2016.
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DOI:
10.1073/pnas.1715368115
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发表时间:
2018-03-06
影响因子:
11.1
通讯作者:
Ledley FD
Ledley FD
中科院分区:
综合性期刊1区
文献类型:
--
作者:
Galkina Cleary E;Beierlein JM;Khanuja NS;McNamee LM;Ledley FD

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这份报告显示,从2010年到2016年,NIH资助了与食品和药物管理局批准的210种新药中的每一种相关的已发表研究。这项研究总共涉及>200,000年来总计超过1000亿美元的赠款资助。分析表明,这笔资金的90%用于与药物作用的生物靶标相关的基础研究,而不是药物本身。因此,NIH资金的作用是对主要专注于应用研究的行业研究和开发的补充。这项工作突显了公共投资开发新疗法的气息和重要性,以及减少研究资金将减缓治疗病态疾病的管道的风险。这项工作审查了2010-2016年间NIH资助与食品和药物管理局批准的210个新分子实体(NME)相关的已发表研究的贡献。我们在PubMed中确定了200万篇与210个NME(n=131,092)或其151个已知生物目标(n=1,966,281)有关的出版物。其中,60万(29%)与美国国立卫生研究院资助的项目有关。这笔资金包括国家卫生研究院200,000个财政年度的项目支持(1985年至2016年)和项目成本&1,000亿美元(2000年至2016年),占这一时期∼预算的20%。国家卫生研究院为2010-2016年核准的每一个国家生态系统提供资金,主要集中在药物目标上,而不是国家海洋生态系统本身。在此期间,有84个一流产品获得批准,这些产品与数十亿美元的美国国立卫生研究院资助项目有关。对于通过定向筛选发现的NME,通过目标搜索而不是药物搜索确定的财政年度项目资金的百分比高于通过表型方法发现的NME(95%比82%)。对于有针对性的近海生态系统,与目标有关的供资先于与近海生态系统有关的供资,这与基础研究为定向筛选提供有效目标的期望是一致的。这一分析涵盖了关于生物靶标的基础研究以及关于NME的应用研究,表明NIH对与新药批准相关的研究的贡献比之前认识到的更大,并突显了减少联邦对基础生物医学研究的资助的风险。
This report shows that NIH funding contributed to published research associated with every one of the 210 new drugs approved by the Food and Drug Administration from 2010–2016. Collectively, this research involved >200,000 years of grant funding totaling more than $100 billion. The analysis shows that >90% of this funding represents basic research related to the biological targets for drug action rather than the drugs themselves. The role of NIH funding thus complements industry research and development, which focuses predominantly on applied research. This work underscores the breath and significance of public investment in the development of new therapeutics and the risk that reduced research funding would slow the pipeline for treating morbid disease. 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.
DOI: 10.1177/009286150403800301
发表时间: 2004-01-01
影响因子: --
作者:
DiMasi, JA;Grabowski, HG;Vernon, J
通讯作者: Vernon, J
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发表时间: 2009-09-01
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影响因子: 6.3
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