2003
Primary Health Care Policy Fellowship

Campaign to Link Advances in Science with People
(CLASP)

Paul Darden, M.D.
Ambulatory Pediatric Association

William Hueston, M.D.
Society of Teachers of Family Medicine

David Kelly, Ph.D., R.N.
Division of Health Careers Diversity and Development, BHPr, HRSA

Paul Marantz, M.D., M.P.H.
Association of Teachers of Preventive Medicine

Allen Shaughnessy, Pharm.D., R.Ph.
American College of Clinical Pharmacy

Campaign to Link Advances in Science with People
CLASP)

Purpose: To improve the health of Americans and to support the goals of the National Institutes of Health by expanding its research capabilities into networks of community practices so we can realize the possibilities of twenty-first century health care.

Statement of Problem: The United States invests over $27 billion dollars a year in health-related research through the National Institutes of Health (NIH). Most of these funds are invested in laboratory research that has expanded our basic knowledge of the biological sciences and genetics. However, we lack the mechanism to link these new discoveries to the health of all Americans. The NIH recognizes this deficiency and is proposing a strategy that encompasses the testing of discoveries in specialized units located in research institutions. But this tactic does not take advantage of the diversity of Americans or the breadth of health care problems they encounter in their communities.

Recommendation: The CLASP initiative would require the NIH to invest at least 1.2% of its annual budget to build and nurture networks of practicing clinicians who can link typical patients and their problems with scientific discoveries. This dedicated funding would be phased in over four years.

This funding will be used to:

• Expand current practice-based research networks, which cut across NIH institutes
• Develop new practice-based research networks
• Create training opportunities designated for primary care clinician-researchers
• Solicit research ideas from primary care researchers
• Fund investigator-initiated, peer-reviewed research projects in primary care

No new funding needed:

• Funds should be available because of the doubling of the NIH budget since 1998
• Some funds are being spent for clinical research networks already, but are used inefficiently. Currently, every clinical trial builds a network of sites only to dismantle this group when the study concludes. Providing dedicated funding for network development and maintenance will allow study networks to become "living laboratories" that provide a renewable resource for research.

Why primary care-based research networks (PBRNs):

• PBRNs provide a well-characterized, representative sample of a diverse set of people in the U.S. as potential participants in patient-oriented research, clinical trials, and effectiveness research.
• PBRNs build on the foundation of pre-existing networks into the development of the research infrastructure envisioned by the NIH Director's "Roadmap."
• PBRNs address health issues that affect the largest number of people.
• PBRNs demonstrate the clinical application of laboratory science findings in typical patients.

Appendix

Primary care networks have been effective tools for testing research results in real-life practices with practicing clinicians. The following four examples demonstrate the feasibility of translating basic research into practices by using these networks:

1. Wisconsin Research Network (WrEN): The Wisconsin Research Network was pivotal in the completion of two NIH-funded projects at the University of Wisconsin. The Trial for Early Alcohol Treatment (Project TrEAT) screened 17,695 primary care patients for alcohol use and examined the effectiveness of brief intervention counseling at reducing excessive alcohol intake. The Health Education and Research Trial (HEART) looked at improving the detection and treatment of risk factors for heart disease in primary care practices.
2. Ambulatory Sentinel Practice Network (ASPN): This network studied over 3800 patients who sought care for a headache. About half of these patients would have qualified for CT scanning according to a statement from the National Institutes of Health, whereas only 2% of the patients actually received a CT scan. Seven patients had a delay in diagnosis because they did not receive a CT, and two had a false-negative CT scan that lead to a delay in diagnosis. Had all of the eligible patients received a CT scan according to the NIH guideline, the cost would have been an additional $2 billion.
3. ALLHAT (The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial): A multicenter study of 42,418 patients recruited from 623 clinical sites (many based in primary care practices). In a recent publication, it was reported that thiazide diuretics are the most effective and least expensive initial therapy for hypertension. This important but costly and time-consuming research study involved the development of a major research infrastructure in a network of clinical sites, created specifically for this study and without clear plans to seek future research opportunities. The promise is there -- for instance, the steering committee continues to meet semi-annually for potential future work, and the coordinator for the Northeast region has retained 3 of the 75 Northeast ALLHAT sites to participate in the current ACCORD study -- but the process is haphazard and uncoordinated. It is primarily focused on continuing the analysis of data already collected, rather than exploiting this research infrastructure for new, creative research that can be done more quickly, cheaply, and effectively.
4. PROS (Pediatric Research in Office Settings): A watershed study involving 225 pediatricians and over 17,000 girls 3 to 12 years of age redefined what is considered normal sexual maturation. These data suggested that girls develop pubertal characteristics at younger ages than then current norms and that there were racial differences. Based on this study there is a need to revise the criteria for referral of girls with precocious puberty, with attention to racial differences.

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