Financing of US Biomedical Research and New Drug Approvals across Therapeutic Areas
Financing of US Biomedical Research and New Drug Approvals across Therapeutic Areas
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DOI：
10.1371/journal.pone.0007015
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发表时间：
2009-09-11
期刊：
影响因子：
3.7
通讯作者：
Moses, Hamilton, III
中科院分区：
文献类型：
--
作者：
Dorsey, E. Ray;Thompson, Joel P.;Moses, Hamilton, III
背景：我们估计了美国跨治疗领域的生物医学研究经费，确定了与疾病负担的关系，并评估了由这些投资产生的新药批准。方法/主要发现：我们计算了1995年至2005年的资金，并主要使用公共数据计算了食品和药物管理局在八个治疗领域（心血管、内分泌、胃肠道、泌尿生殖系统、艾滋病毒/艾滋病、不含艾滋病毒的传染病、肿瘤和呼吸系统）的批准总数。然后，我们计算了资金、公布的疾病负担估计和药物批准之间的相关性。1995年至2005年，所有治疗领域对生物医学研究的财政支持增加了43%至369%。除了艾滋病毒/艾滋病、传染病和肿瘤学以外，工业界是所有领域的主要资助者，这些领域主要由美国国立卫生研究院（NIH）赞助。总（r = 0.70; P = 0.03）和行业资助（r = 0.69; P = 0.04）与高收入国家预计的疾病负担相关，而NIH支持（r = 0.80; P = 0.01）与全球预计的疾病负担相关。从1995年到2005年，整个治疗领域的新批准数量持平或下降，在8年的滞后期内，无论是总数还是行业资金都与未来的批准无关。结论/意义：在整个治疗领域，生物医学研究经费大幅增加，似乎与高收入国家的疾病负担一致，但与新药批准无关。资金和新疗法之间的转化差距正在影响所有医学，补救措施必须包括除了额外的财政投资之外的变化。
Background: We estimated U.S. biomedical research funding across therapeutic areas, determined the association with disease burden, and evaluated new drug approvals that resulted from this investment.Methodology/Principal Findings: We calculated funding from 1995 to 2005 and totaled Food and Drug Administration approvals in eight therapeutic areas (cardiovascular, endocrine, gastrointestinal, genitourinary, HIV/AIDS, infectious disease excluding HIV, oncology, and respiratory) primarily using public data. We then calculated correlations between funding, published estimates of disease burden, and drug approvals. Financial support for biomedical research from 1995 to 2005 increased across all therapeutic areas between 43% and 369%. Industry was the principal funder of all areas except HIV/AIDS, infectious disease, and oncology, which were chiefly sponsored by the National Institutes of Health (NIH). Total (r = 0.70; P =.03) and industry funding (r = 0.69; P = .04) were correlated with projected disease burden in high income countries while NIH support (r = 0.80; P = .01) was correlated with projected disease burden globally. From 1995 to 2005 the number of new approvals was flat or declined across therapeutic areas, and over an 8-year lag period, neither total nor industry funding was correlated with future approvals.Conclusions/Significance: Across therapeutic areas, biomedical research funding increased substantially, appears aligned with disease burden in high income countries, but is not linked to new drug approvals. The translational gap between funding and new therapies is affecting all of medicine, and remedies must include changes beyond additional financial investment.