NIH peer review of grant applications for clinical research.

CONTEXT 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. OBJECTIVE To describe recent trends and outcomes of peer review of grant applications to NIH requesting support for clinical research. DESIGN AND SETTING 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. MAIN OUTCOME MEASURES Median priority scores and funding rates. RESULTS 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. CONCLUSION 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.

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