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Applications for grants to fund clinical studies do not fare as well in the National Institutes of Health's peer review process as do those for nonclinical studies, according to an NIH report released yesterday (July 14).

The report, which was conducted by NIH's Center for Scientific Review (CSR) and appears in this month's edition of The American Journal of Medicine, says that clinical grant applications have lower acceptance rates mainly because clinical researchers are less likely to apply for grant extensions than are their nonclinical counterparts.

"We were criticized all the time that clinical research doesn't fair well in peer review," said Toni Scarpa, director of CSR but not an author on the report, explaining that the center conducted the study to determine whether the problem lay with the peer review process itself or was the result of other factors. "It seems that it is something else."

The CSR, NIH's main grant application review body, revisited nearly 93,000 R01 applications - 67.5 percent were clinical and 32.5 percent were nonclinical - submitted from October 2000 to 2004. On average, the nonclinical grant applications were ranked higher than clinical ones for a variety of reasons. One reason, according to the report, is that clinical study applications sometimes fail to adequately address how researchers plan to protect human trial subjects. Scarpa said that some researchers were simply "sloppy" in documenting protections for patients in grant applications rather than the protections being absent from the studies.

The key factor leading to the discrepancy in acceptance rates between clinical research and basic science grants, however, was the fact that clinical study researchers tended not to reapply for further NIH funding, which tends to be more readily approvable. The report states that only 20 percent of the clinical researchers who landed an R01 submitted competing renewal applications while 28.3 percent of nonclinical R01 grant awardees did. "We're still concerned that a lot of [clinical researchers] who get awards sort of disappear from science," Scarpa said.

Scarpa did say that the study's results suggest that the NIH peer review system itself is not to blame for the imbalance between clinical and basic research grant awards. "I feel a little more satisfied that the problem might not be with us," he said. This study, Scarpa continued, did not mend the discrepancy between clinical and basic research awards. "These data don't solve the problem," he said, "they simply try to explain it."

Scarpa said that the CSR would work with academic institutions, industry groups, and research hospitals to encourage clinical researchers to apply for continuations to their NIH grants in order to increase the overall acceptance rates for clinical study grants. "It's one of the missions of the NIH to have a balanced portfolio between basic and clinical research," he said.