Contribution of NIH funding to new drug approvals 2010-2016
Autor: | Ekaterina Galkina Cleary, Jennifer M. Beierlein, Fred D. Ledley, Laura M. McNamee, Navleen Surjit Khanuja |
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Rok vydání: | 2018 |
Předmět: |
0301 basic medicine
medicine.medical_specialty Biomedical Research translational science New Drug Approvals Social Sciences basic science Food and drug administration Translational Research Biomedical 03 medical and health sciences 0302 clinical medicine Basic research Neoplasms Drug Discovery medicine Humans Targeted screening Applied research 030212 general & internal medicine Drug Approval health care economics and organizations Multidisciplinary business.industry Financing Organized Nih funding drug development United States 030104 developmental biology Drug development National Institutes of Health (U.S.) Family medicine Translational science NIH funding business |
Zdroj: | Proceedings of the National Academy of Sciences of the United States of America |
ISSN: | 1091-6490 |
Popis: | Significance 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. |
Databáze: | OpenAIRE |
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