Kotchen Theodore A, Lindquist Teresa, Malik Karl, Ehrenfeld Ellie
Center for Scientific Review, National Institutes of Health, Bethesda, Md, USA.
JAMA. 2004 Feb 18;291(7):836-43. doi: 10.1001/jama.291.7.836.
Support of research to facilitate translation of scientific discoveries to the prevention and treatment of human disease is a high priority for the US National Institutes of Health (NIH). Nevertheless, a perception exists among clinical investigators that the NIH peer review process may discriminate against clinical research.
To describe recent trends and outcomes of peer review of grant applications to NIH requesting support for clinical research.
Peer review outcomes of grant applications submitted to NIH by MDs were compared with those of non-MDs, and outcomes of applications involving inclusion of human subjects were compared with those not involving human subjects. Analyses were carried out using an inclusive definition of clinical research and after stratifying clinical research into specific categories.
Median priority scores and funding rates.
Between 1997 and 2002, on average, 25.2% of total grant applications (ranging from 27 607 to 34 422 per year) were submitted by MDs, and 27.5% of awards (ranging from 8495 to 10 769 awards per year) were made to MDs. Median priority scores (239.0 vs 250.0) and funding rates (31.4% vs 29.1%) reviewed in 2 grant cycles in 2002 were more favorable for MDs than for non-MDs (P<.001). However, median priority scores (254.0 vs 244.0) and funding rates (23.9% vs 28.1%) were less favorable (P<.001) for R01 applications for clinical research (n = 7227 applications) than for nonclinical research (n = 10 209). This trend was most convincingly observed for clinical research categorized as mechanisms of disease (P =.006) or clinical trials and interventions (P =.001). Similar trends were observed for grant mechanisms other than R01. Concerns about safety and privacy of human subjects may have contributed to the less favorable outcomes of clinical research applications.
Although physicians compete favorably in the peer review process, review outcomes are modestly less favorable for grant applications for clinical research than for laboratory research.
支持开展研究以促进将科学发现转化为人类疾病的预防和治疗手段，是美国国立卫生研究院（NIH）的一项高度优先任务。然而，临床研究人员中存在一种看法，即NIH的同行评审过程可能对临床研究存在歧视。
描述向NIH提交的请求支持临床研究的资助申请的同行评审的近期趋势和结果。
比较医学博士向NIH提交的资助申请的同行评审结果与非医学博士的申请结果，以及涉及纳入人类受试者的申请结果与不涉及人类受试者的申请结果。使用临床研究的包容性定义并将临床研究分为特定类别后进行分析。
中位优先级分数和资助率。
1997年至2002年期间，平均每年资助申请总数的25.2%（每年从27607份至34422份不等）由医学博士提交，每年资助奖励的27.5%（每年从8495项至10769项不等）授予医学博士。2002年两个资助周期中评审的中位优先级分数（239.0对250.0）和资助率（31.4%对29.1%），医学博士的情况比非医学博士更有利（P<0.001）。然而，临床研究的R01申请（n = 7227份申请）的中位优先级分数（254.0对244.0）和资助率（23.9%对28.1%）比非临床研究（n = 10209份）更不利（P<0.001）。这种趋势在归类为疾病机制（P = 0.006）或临床试验及干预措施（P = 0.001）的临床研究中最为明显。对于R01以外的资助机制也观察到类似趋势。对人类受试者安全和隐私的担忧可能导致了临床研究申请的结果不太理想。
尽管医生在同行评审过程中具有竞争力，但临床研究资助申请的评审结果比实验室研究的申请结果略逊一筹。
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