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Although the need to translate basic science discoveries into the clinical arena is widely acknowledged, a new study by researchers at the Medical College of Wisconsin, in Milwaukee, and National Institutes of Health (NIH) identified reasons why clinical science grant applications receive less positive peer reviews than basic science grant applications to the NIH. The findings were published in the July issue of The American Journal of Medicine.

In collaboration with Michael R. Martin, Ph.D., and Teresa Lindqusit, MS, at NIH's Center for Scientific Review CSR), Dr. Theodore Kotchen, associate dean for clinical research and professor of medicine at the Medical College, studied 92,922 grant applications submitted to NIH between October 2000 and May 2004. Of that number, 67.5 percent were considered basic science applications and 32.5 percent were considered clinical applications. Dr. Kotchen is special advisor on clinical research to the NIH's CSR.

They found that investigators conducting clinical research were less likely to submit a continuing, competitive renewal grant application than investigators conducting basic research (20.0% vs. 28.3%). However, renewal applications generally receive more favorable reviews than new applications. The study concluded that approximately one-half of the observed differences in peer review outcomes for clinical versus basic research applications can be attributed to the lower rate of resubmission by clinical applicants.

Another reason for differences in review outcomes was related to applicants failing to adequately address human subject concerns in their applications. Human subject concerns, which the NIH defines as any potential or actual unacceptable risk or inadequate protection against risks to human subjects, were identified in 15% of clinical grant applications.

"Applications cited for having human subject concerns do not necessarily mean that the science is less meritorious," says Dr. Kotchen.

"Human subject concerns raised at the time of review may reflect inadequate explanation by the investigator in the protection of human subjects section of the application. Further instructions clarifying how to complete the human subject section of grant applications may be necessary.

"The message to applicants is that failure to provide complete information about plans for protecting human subjects may result in a less favorable priority and could adversely affect the likelihood of funding."

According to Kotchen, "There are continuing national concerns about the robustness of the clinical research enterprise. This includes a shortage of clinical investigators, the attrition of experienced clinical investigators, lack of adequate infrastructure at academic medical centers, and the financial burden faced by promising young scientists."

He points out that, "The clinical research enterprise would benefit from an informed understanding of the factors contributing to the attrition of experienced clinical investigators."

Clinical research grants were defined as any grants that include involvement of human subjects. This definition includes research on mechanisms of disease, therapeutic interventions, clinical trials, development of technologies, epidemiological and behavioral studies outcomes, and health services research.

Medical College of Wisconsin
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