NIH Funds Likelier to Go to Nonhuman Research

Agency denies bias against clinical trials

TUESDAY, Feb. 17, 2004 (HealthDayNews) -- Researchers seeking funding from the National Institutes of Health (NIH) are more likely to get grants for nonhuman research than studies of people.

A new report -- funded by the NIH and conducted by reviewers affiliated with it -- finds that while clinical researchers "compete favorably" in the peer review process, their funding outcomes are "modestly less favorable" than those seeking money for nonclinical research. (Clinical research, by definition, involves human subjects.)

The NIH, the premier medical funding agency of the U.S. government, expects to receive almost $28 billion of taxpayer money this year, most of it earmarked for health-care research.

A review of grant applications from 1997 to 2000 that compared research involving human subjects with research that didn't found that proposals for nonhuman research were more likely to be approved.

The finding appears in a report in the Feb. 18 issue of the Journal of the American Medical Association.

"There is a disparity between money given to nonhuman and human research," says study author Dr. Theodore A. Kotchen, a professor of medicine at the Medical College of Wisconsin. Kotchen is an advisor to the NIH's Center for Scientific Review (CSR), which oversees some 70 percent of grant applications submitted to the agency.

The researchers found that approximately 25 percent of nonclinical grants were funded, compared to only about 20 percent of grants involving human subjects.

"This disparity may be due, in part, to the greater challenges of conducting studies in humans than in laboratory animals," Kotchen says. These challenges are related to safety and ethical issues and the difficulty in controlling the research environment in human studies, he explains.

However, Kotchen believes the "NIH is especially interested in applying the observations from basic research to the study of health and disease in humans."

Kotchen also says the NIH is not biased against human research. Rather, the disparity in grant giving is due to many factors, including the difficulty of doing human research and the need for clinical investigators to write better grant applications.

But he also thinks the groups that review grant applications may include more research scientists than clinical researchers, and this is something his team is still investigating.

The process for reviewing grants needs to be friendlier to clinical grant applications, Kotchen says. "We need to better understand the reasons for this disparity. But it is also clear that clinical research needs greater support."

Karl Malik, assistant to the director and associate director of the Office of Evaluation, Planning and Analysis at the CSR, takes a different view of the findings. "I don't know if there is a problem or not," he says.

Malik's office reviews and approves or denies most of the grant applications sent to the NIH.

Malik says the difference in funding between human and nonhuman research grants is small. Most of this difference, he says, seems to be due to safety and privacy concerns for human subjects. "Making sure that clinicians are careful in addressing these concerns" can close this small gap, he says.

"We want to make sure that all applications are reviewed appropriately and fairly. We see these small differences and we will continue monitoring it and we will see if we can get to the root cause of this difference," Malik says.

Whether more clinical research is needed is something Malik says he is not qualified to comment on.

Dr. Ralph Snyderman, chancellor of health affairs at Duke University, says that, at the NIH, "there is an unintentional bias against clinical research and toward laboratory-based research."

In the past 20 years there has been a revolution in biomedical research, which has caused a backlog of information that hasn't been translated into improving people's health, says Snyderman, who wrote an editorial accompanying the article.

"To get these improvements in health care we need a much more robust system of clinical research," he adds. "The question is how do you get the tens of billions of dollars of research into better health care," Snyderman says.

One way, he says, is to spend more money on training clinical researchers. "Schools of medicine, teaching hospitals and the medical professions need to be doing more to understand and appreciate the value of the clinical researcher as a profession," Snyderman adds.

"We are getting close to a crisis in the difference between the actual practice of clinical care and what it's capable of doing," he says. "This discrepancy is costing us tremendously in the quality of health care and in patients not getting the benefits they should be getting."

More information

For more on medical research, try the National Institutes of Health or the Agency for Healthcare Research and Quality.

SOURCES: Theodore A. Kotchen, M.D., professor, medicine, Medical College of Wisconsin, Milwaukee; Karl Malik, Ph.D., assistant to the director and associate director, Office of Evaluation, Planning and Analysis, Center for Scientific Review, National Institutes of Health, Bethesda, Md.; Ralph Snyderman, M.D., chancellor, health affairs, and professor, medicine and immunology, Duke University, Durham, N.C.; Feb. 18, 2004, Journal of the American Medical Association
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