Contents
- CTSAs IN FOCUS
Clinical Research Associate Networks
CTSAs in Focus
Updates on the Clinical and Translational Science Awards
Clinical Research Associate Networks
Translational research, often referred to as “bench to bedside,” translates knowledge gleaned from laboratory findings to potential treatments for diseases. But there is a second aspect to this research—assessing the usefulness of these advances to patients.
Often, studies that engage patients require the involvement of community-based physicians and nurses. Through its Roadmap initiative “Re-engineering the Clinical Research Enterprise,” NIH has awarded supplemental funds to four members of the Clinical and Translational Science Awards (CTSA) consortium—Columbia University Health Sciences, Duke University, Mayo Clinic College of Medicine, and University of Rochester—to determine the necessary components for creating and maintaining networks of community-based medical providers who are qualified, trained, and eager to participate in research studies.
These networks—referred to as clinical research associates networks or organizations—have several important functions, according to Lloyd Michener of the CTSA-funded Duke Translational Medicine Institute and co-chair of the Community Engagement Steering Committee for the CTSA consortium. “They help connect CTSA institutions to diverse patients who represent a wide variety of conditions,” he explains. “They help provide support to medical practices to conduct clinical research. And they help researchers understand disease at the population level.”
Duke already has established a network of primary care physicians, the Duke Primary Care Research Consortium, who work together to enroll patients in clinical research studies. The consortium involves 25 practices with 29 sites in eight counties of North Carolina’s Piedmont area. Since its inception in 1997, the consortium has enrolled more than 3,000 subjects in more than 50 trials.
With the supplemental support from NIH, the Duke Translational Medicine Institute is assessing the feasibility of expanding this network to include physicians at more practices and specialty physicians. “We will be sending a survey to 1,000 physicians to gauge their level of interest in clinical research,” says Rowena Dolor, director of the Duke Primary Care Research Consortium. Based on the survey results, Dolor and colleagues will develop different education modules for supporting research at these sites. They will also survey the clinical studies currently approved by Duke’s Institutional Review Board to select ones that would be good candidates for involving community providers.
“The CTSA would function as a clearinghouse for multicenter clinical studies that require provider identification, training and certification, and study-specific support,” explains Dolor. “Some practices have dedicated research staff, and all we would need to do is offer a study to them—provided that they have the necessary certification; others would need us to send a study coordinator for subject enrollment and follow-up.”
Dolor is currently gathering data on the feasibility and cost of running this type of organization. The other three CTSA-funded centers that received comparable NIH supplements are asking similar questions using different approaches. “Some are conducting focus groups; others are setting up practice-based research networks,” says Dolor.
Although networks of primary care physicians and researchers have existed for many years, explains Michener, “what is new is the degree of formalization and connection to the community we are trying to achieve. The research organizations we are implementing span all diseases and conditions. It is really exciting.”
UPCOMING MEETING
The CTSA Community Engagement Steering Committee will hold a workshop entitled “Accelerating the Dissemination and Translation of Clinical Research into Practice” on May 9, 2008, on the NIH campus in Bethesda. For information about the workshop and to register to attend, visit www.aptrweb.org/workshops.
The Clinical and Translational Science Awards (CTSA) program is a national consortium designed to transform how biomedical research is conducted across the country. Its goals are to speed the translation of laboratory discoveries into treatments for patients, as well as to train the next generation of clinical researchers. The CTSA program is led by NCRR. For more information, visit CTSAweb.org.
