NIH clinical trial initiative: Agency reaches out to primary care

The research needs of primary care physicians can be met through networks where questions spring from shared experience.

By Susan J. Landers — Posted May 24, 2004

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Washington -- Community-based physicians do not often look to the vast National Institutes of Health for answers to questions that haunt them daily, whether they involve the care of diabetic patients or the expeditious handling of lab results.

But NIH is considering reaching out to these doctors and their patients as resources for some of its many clinical trials.

"There is a segment of the physician and patient community that is rarely involved in clinical research activities," noted Duane Alexander, MD, director of the National Institute of Child Health and Human Development. As a first step, a feasibility study will be conducted that will include assessing physician interest in becoming a part of a new network, he said.

Many primary care physicians, however, as well as those in other specialties, have not been waiting for an invitation from NIH but have been enrolling their patients in clinical trials for years. They belong to one of the more than 100 such networks that explore questions that strike close to home.

These networks, which could serve as a model for the NIH initiative, have examined such varied issues as the management of laboratory test results in family practices and the effect of a patient's insurance status on treatment decisions. Several networks are now determining the best ways to motivate patients to adopt healthier lifestyles.

The NIH proposal to tap community physicians as well as dentists and nurse practitioners and their patients as a resource was put forward as part of a "roadmap" for future NIH research by NIH Director Elias Zerhouni, MD.

"At the end of the day, all of our efforts will come to naught if we do not translate [research findings] into clinical practice," said Dr. Zerhouni, speaking to physicians at the AMA's annual national advocacy conference this spring.

There has been a major shift in medicine from the treatment of acute conditions to chronic conditions and disease prevention, thus moving the focus from academic medical centers to communities, he said. Dr. Zerhouni envisions a future of standardized data reporting from large clinical research networks that include academic centers and community physicians.

If the NIH proposal were enacted, participation in clinical trials could add interest to participating physicians' practices by providing patients an opportunity that might not otherwise be available, Dr. Alexander said.

The right questions

Many of the existing primary care research networks receive funding from the federal Agency for Healthcare Research and Quality. AHRQ has provided about $8 million to the networks during the past decade and was recently joined by the Robert Wood Johnson Foundation, which provided $2.1 million in grants to fund networks that are developing strategies that primary care physicians can use to help patients change unhealthy behaviors.

"Sometimes community physicians look at the NIH and say, 'You don't answer the questions that I encounter in practice,' " said David Meyers, MD, a medical officer with AHRQ.

Dr. Meyers had been the director of a research network of primary care physicians in the Washington, D.C., area before joining the agency to promote its effort to broaden support provided to these networks.

The basic idea is that practicing physicians who are out there doing medicine every day is where research has to take place, Dr. Meyers said.

Increased interest in primary care research networks also demonstrates a recognition by the NIH of the importance of communities and the physicians who care for those communities, Dr. Meyers said.

NIH is beginning to see the value of including community practices and primary care in its research, if for no other reason than to overcome the disconnect that can occur between the research done in academic medical centers and its translation into primary care settings, said James M. Galliher, PhD, research director of the American Academy of Family Physicians' research network.

The AAFP's Federation of Practice Based Research Networks recently joined with federal agencies for two research studies. Networks of family physicians have embarked on one trial with the National Heart, Lung, and Blood Institute to study the use of spirometry in primary care and another to evaluate a family medical history project begun by the Centers for Disease Control and Prevention.

John H. Wasson, MD, professor of community and family medicine at Dartmouth Medical School and the principal investigator for the Dartmouth/Northern New England Primary Care Cooperative Research Network, takes a more skeptical view of the increased NIH attention. He fears that increased bureaucracy could be fatal to research networks.

If the NIH is going to do large-scale studies in communities, Dr. Wasson said, there should be funding for ideas that "bubble up" from physicians, as occurs now in primary care research networks.

"When you have things dictated from so-called experts, you are killing innovation," he said.

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Primary care practice-based research networks were first developed in the United States in the late 1970s and have received some federal funding, primarily from the Agency for Healthcare Research and Quality during the past 10 to 15 years. Among the projects supported by AHRQ since 1993:

  • A descriptive study of the referral process in pediatric care, conducted in the Pediatric Research in Office Settings network of the American Academy of Pediatrics.
  • A study of primary and secondary prevention of coronary artery disease and stroke in primary care settings, conducted by the Practice Partner Research Network of the University of South Carolina.
  • Research to characterize medical errors in primary care settings, conducted by the Virginia Ambulatory Care Outcomes Research Network of Virginia Commonwealth University.
  • A study of the role of antibiotics in improving outcomes for children with acute otitis media, conducted by the Ambulatory Sentinel Practice Network in collaboration with other primary care networks in the Netherlands and the United Kingdom.

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Crafting a roadmap

A series of National Institutes of Health meetings on the future of medical research in the 21st century has resulted in a "roadmap" for accelerating discoveries and improving people's health. It includes the re-engineering of the clinical research enterprise to continue the translation of basic research discoveries into drugs, treatments or preventive methods.

The plan calls for:

  • Establishing a cadre of NIH clinical research associates composed of community-based practitioners on the front lines of care who will receive specialized training in clinical research. These individuals will play a critical role both in advancing the discovery process and disseminating research findings to the community.
  • Enhancing the clinical research enterprise with the support of a series of clinical research networks to rapidly conduct high-quality clinical trials and research.
  • Developing a standardized data system, the National Electronic Clinical Trials and Research Network (NECTAR), to facilitate the sharing of data and resources and augment research performance and analysis.

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External links

National Institutes of Health Roadmap (link)

Fact sheet on primary care practice-based research networks from the Agency for Healthcare Research and Quality (link)

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