Practice-Based Research Gains Foothold at NIH

Under pressure from the Academy, Congress and other sources, NIH is beginning to signal its growing recognition of the importance of practice-based research, say several FP leaders. Signs of this increasing valuation include a new type of NIH grant, continuing AAFP discussions with NIH institutes, and a Senate committee report that uses language the AAFP and the Academic Family Medicine Advocacy Alliance recommended.

"Slowly but surely, the NIH is recognizing the absolute need to fund research in the community setting, such as research through practice-based research networks," says Herbert Young, M.D., director of the AAFP Scientific Activities Division.

An NIH grant program that announced its first 12 recipients in October calls for "community engagement" in research. The five-year Clinical and Translational Science Awards, or CTSAs, are part of the NIH Roadmap for Medical Research, which outlines a continuum from basic science research to human clinical research and then to clinical practice.

A small portion of funds from a five-year, $43 million CTSA will help the University of Rochester, N.Y., create an office for practice-based research networks, says Thomas Campbell, M.D., chair of the university's family medicine department. "We'll find out what the community physicians perceive as barriers to practice-based research, and we'll see how to overcome the barriers and get more practices engaged. We'll create a database of community practices so we have a better sense of the types of patients, including groups, that may have disparities in care. Our coordinators will go into practices and help them do research."

However, with academic awards come intense battles for available finances, says Campbell. "All the money's accounted for two and three times over. The CTSA could change the face of practice-based research. Whether it will is to be seen."

According to Campbell, NIH wants to involve practicing physicians in NIH-sponsored research, so that if an NIH study pertains to Parkinson's disease, community physicians would identify patients with Parkinson's and participate with them in part of the research. "If the community physicians' response is, 'No thanks, we don't want to do that,' obviously, this NIH plan won't get very far," says Campbell.

Another FP says part of his institution's five-year, $55 million CTSA will fund "a concierge service for research," making it easier for researchers to write grant applications and obtain funding. Lyle Fagnan, M.D., an associate professor in family medicine at Oregon Health & Science University, Portland, directs the Oregon Rural Practice-Based Research Network, based at the university.

"Often, clinical guidelines don't get used in practice," says Fagnan. "Our network provides a research lab that allows us to test guidelines. And the CTSA will allow us to bridge research silos. Cardiologists want to know how to handle myocardial infarctions in small communities. The CTSA will allow the cardiologists to link with family physicians in the communities."

Since before the CTSA became a reality, officers at several NIH institutes have lent an ear to FP researchers' pitches for practice-based research. The Academy's ongoing research advocacy efforts have featured meetings with officials at the National Heart, Lung and Blood Institute; National Cancer Institute; National Institute of Mental Health; National Institute on Alcohol Abuse and Alcoholism; and National Institute of Diabetes and Digestive and Kidney Diseases. Continuing to cultivate relationships with these five institutes, says Young, offers great promise when it comes to funding practice-based research.

In addition, "Since last year, a multi-institute program announcement from NIH has sought applications for grants to disseminate and implement research, and NHLBI and NCI are funding some of this work," says James Mold, M.D., M.P.H., head of the research advocacy group of the AAFP Commission on Science and a professor and research director in the family and preventive medicine department at the University of Oklahoma Health Sciences Center, Oklahoma City. "NIH is beginning to invest" in implementation at the practice level, he says.

There's an additional reason to be positive about resources for practice-based research. Last year, for the first time, the Senate Appropriations Committee encouraged NIH to support such research. "The committee urges NIH to begin discussions to determine how best to facilitate progress in translating existing research findings and to disseminate and integrate these findings at the practice level. Translational research should also include the discovery and application of knowledge within the practice setting using such laboratories as practice-based research networks. This research spans biological systems, patients and communities, and arises from questions of importance to patients and their physicians, particularly those practicing primary care," says part of the committee's section on translational research in its 2006 report.

According to Young, the Academy and the Academic Family Medicine Advocacy Alliance recommended the above statement to the Senate committee. The provision does not have the force of law, but it does indicate the position of the Senate panel that makes funding recommendations.

NIH's budget was about $28 billion in fiscal year 2006, and legislators want to know what their constituents are getting for those funds, says Mold. "That's what all the commotion is about -- NIH feels pressure to show that all the basic research is really making a difference in terms of human health."

"The problem is," Mold adds, "NIH has never really dealt much with the messy stuff, the 'getting research into practice' part. Many NIH clinical trials exclude people who are old or have multiple chronic problems or are on too many medications or are not likely to comply -- things like that. And sometimes the trials haven't asked the questions that matter in practice."

So, says Mold, "The Academy and others, such as the Agency for Healthcare Research and Quality, have to keep advocating relevant, practice-based research and seeking a seat at the table where people are talking about research dollars. It's a long-term proposition."