Funding for patient-oriented research - Critical strain on a fundamental linchpin

Funding for patient-oriented research - Critical strain on a fundamental linchpin
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DOI:
10.1001/jama.278.3.227
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发表时间:
1997-07-16
影响因子:
120.7
通讯作者:
Carbone, P
Carbone, P
中科院分区:
医学1区
文献类型:
--
作者:
Williams, GH;Wara, DW;Carbone, P

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背景-在过去的20年里,人们对临床研究职业的兴趣有所下降。虽然这一下降可能涉及几个因素,其中之一是在获得对研究人员发起的临床研究项目的支持方面的感知困难。目标-分析当国家卫生研究院(NIH)研究拨款部门审查对NIH的拨款申请时,以患者为中心的研究(POR)与以实验室为导向的研究(LOR)的优先分数和资助率。设计-申请人将提交给NIH的研究拨款申请归类为是否涉及人类受试者(LOR)。被归类为涉及人类受试者的研究分为临床研究(POR)和非临床研究。使用CHI(2)统计技术评估了优先分数与POR或LOR状态的关系。-在1994年NIH审查周期中的两个周期中,1.2万名研究人员发起的拨款申请(R01)。主要结果衡量标准。-授予申请优先级分数和资助率。结果-根据以下3个标准,POR申请的情况不如LOR申请:(1)POR状态和在总申请池中的排名;(2)POR与LOR申请在前20个百分位数中的百分比;以及(3)POR申请的资金率。此外,POR申请的命运取决于哪个研究部门审查了该申请。在主要审查POR申请的研究部分中审查的那些申请与LOR申请的进展相同;相反,在主要审查LOR申请的研究部分中审查的POR申请遇到了不太有利的命运。结论-这些客观数据为临床研究界的担忧提供了强有力的支持,即研究人员发起的POR申请在NIH没有得到公平审查。通过重组审查程序,很可能恢复公平。如果不进行重组,医学研究界的POR部分可能会受到严重损害。
Context.-Interest in clinical investigative careers has declined over the past 2 decades. While several factors are likely involved in this decline, one is the perceived difficulty in obtaining support for investigator-initiated clinical research projects.Objective.-To analyze the priority scores and funding rates of patient-oriented research (POR) compared with laboratory-oriented research (LOR) when grant applications to the National Institutes of Health (NIH) are reviewed by study sections of the NIH Division of Research Grants.Design.-Research grant applications submitted to NIH were classified by the applicant as involving human subjects or not (LOR). Those classified as involving human subjects were divided into clinical (POR) and nonclinical research. The association of priority score and POR or LOR status was evaluated using chi(2) statistical techniques.Setting and Participants.-Twelve thousand investigator-initiated grant applications (R01s) in 2 of the 1994 NIH review cycles.Main Outcome Measures.-Grant application priority scores and funding rates.Results.-On the basis of the following 3 criteria, POR applications fare less well than LOR applications: (1) POR status and ranking in the total application pool; (2) percentage of POR vs LOR applications in the top 20th percentile; and (3) funding rates of POR applications. Furthermore, the fate of a POR application depended on which study section reviewed the application. Those applications that were reviewed in study sections that primarily reviewed POR applications fared equivalently to LOR applications; in contrast, POR applications reviewed in study sections that primarily reviewed LOR applications encountered a less favorable fate.Conclusions.-These objective data provide strong support to the clinical research community's concern that investigator-initiated POR applications are not reviewed equitably at the NIH. By restructuring the review process, fairness is likely to be restored. Without restructuring, the POR component of the medical research community may be critically damaged.