Outcomes of National Institutes of Health peer review of clinical grant applications.

PURPOSE: We previously reported that National Institutes of Health (NIH) peer review outcomes in 2002 were slightly but significantly less favorable for grant applications for clinical research than for laboratory research. The present analysis was undertaken to determine if factors related to the review process might contribute to this difference. METHODS: The impact of each of the following factors on median priority scores and funding rates for clinical and nonclinical R01 grant applications was evaluated: (1) the percentage of clinical applications assigned for review to a study section, (2) the requested direct costs, and (3) the clinical research experience of the reviewers. RESULTS: Confirming our previous observation, in both 1994 and 2004, median priority scores and funding rates for R01 applications were less favorable for clinical research. In 1994, clinical applications did not fare as well in study sections reviewing relatively low percentages of clinical applications. This was not the case in 2004. Although requested direct costs were greater for clinical than for nonclinical R01 applications, median priority scores within each category were actually more favorable for applications requesting greater funding. Assignment of priority scores was not different for reviewers with or without experience conducting clinical research. CONCLUSION: These data do not support the hypothesis that the less favorable review outcomes for clinical applications are related to these review factors. We suggest that peer review outcomes for clinical research will benefit from the recent refinement of NIH review criteria, emphasizing the unique contributions of clinical investigation, and from increased training opportunities for clinical investigators.

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.

Testosterone changes during the period of adolescence in male rhesus monkeys (Macaca mulatta).

Testosterone levels of 59 male rhesus monkeys were monitored over a period of 5 years. Longitudinal comparisons revealed consistent rises in mid-morning levels of circulating hormone in successive years from age 2.5 to 6.5 years of age, whereas cross-sectional comparisons failed to detect significant differences among the older subjects. The first mid-morning hormonal elevation could be detected in some males as young as 2.5 years of age, whereas other males showed no detectable rises until age 5.5 years. Males showing first rises at later ages did not show hormonal levels consistently below age peers who had shown earlier rises. Extreme month-to-month variability and a failure to manifest the seasonal normal curve of fully adult males was characteristic of younger males, but some of these males, nonetheless, proved capable of fertilizing females. Although hormonal and agonistic dominance measures failed to show consistent correlations, the alpha male in an age cohort significantly more often had the highest testosterone levels. These data are used to argue that adolescence is a process that takes place over several years and that classification of adolescent animals as adults, based on a single criterion like fertility, has confounded many prior studies involving cross taxa comparisons as well as developmental variables.

Manipulation of objects in a captive group of lion-tailed macaques (Macaca silenus).

The purpose of this study was to investigate the manipulative propensities of a captive group of lion-tailed macaques (Macaca silenus). Simple natural objects (browse and bamboo poles) were provided regularly in the home cage. Findings indicate richness in the frequency and form of manipulative activities, with juvenile males manipulating the test objects more frequently and exhibiting more goal-directed manipulative activity than adult females. A variety of goal-directed manipulative activities (use of objects to act as ladders, to apply leverage, and to create perches) occurred spontaneously, with some instances involving joint action or social use. These data are consistent with the hypotheses that macaques possess extensive capacities for object exploration and social facilitation, and that an evolutionary history of omnivorous foraging habits correlates positively with the expression of anomalous sensorimotor skills.