Basic biomedical research, with its careful, tightly controlled experiments on cells and laboratory animals, is painstaking work. But some of the challenges of basic science pale next to the hurdles faced by clinical and translational researchers, who test laboratory discoveries in human subjects with the ultimate goal of getting safe and effective new drugs to patients who need them.
In addition to the inherent difficulties of studying people—unlike mice, humans vary widely in genetics and life histories—clinical researchers must orchestrate large, complex studies that require hospital beds, nursing services, statisticians, lab tests, medical imaging and database management, all while navigating the dense thicket of regulations that govern research involving human subjects.
“Doing clinical research was much simpler when I started,” says Robert S. Sherwin, M.D., the C.N.H. Long Professor of Medicine and director of the newly formed Yale Center for Clinical Investigation (YCCI). “Because of the daunting complexities faced by researchers today, we have lost an entire generation of clinicians, many of whom have found it very difficult to sustain their research work.”
But now Sherwin has reason to celebrate. On October 3, the National Institutes of Health (NIH) announced that the School of Medicine had been awarded a five-year, $57.3 million Clinical and Translational Science Award (CTSA), part of a major national initiative that will transform how researchers move laboratory discoveries into human studies. Key participants in the grant—the largest NIH award in the medical school’s history—include the Yale School of Nursing, the Department of Epidemiology and Public Health, the Department of Biomedical Engineering and the Combined Program in the Biological and Biomedical Sciences.
According to Tesheia H. Johnson, M.B.A., M.H.S., the YCCI’s chief operating officer and associate director for clinical research at the medical school, the unprecedented grant will allow the YCCI to train a new generation of interdisciplinary clinical researchers, to launch greater numbers of Phase I studies of drugs discovered by Yale scientists and to forge research partnerships with underserved populations in the community to improve public health.
The School of Medicine was the only academic medical center in New England among the 12 institutions across the nation that received CTSAs, which total nearly $700 million over the next five years. The grants were inaugurated as part of the Roadmap for Medical Research, an ambitious effort to streamline translational research spearheaded by NIH Director Elias A. Zerhouni, M.D. When fully implemented in 2012, the CTSA initiative is expected to provide $500 million annually to 60 centers forming a national consortium.
According to Robert J. Alpern, M.D., dean and Ensign Professor of Medicine, the medical school is ideally positioned to fulfill the mission of the CTSAs. “A strategic planning initiative completed in 2004 targeted clinical research as a priority, establishing the YCCI as a focal point,” Alpern said. “The YCCI’s structure, built on Yale’s strengths in education, basic science, and community-based research, is virtually identical to the vision put forth by the NIH in this new program.”
The educational centerpiece of the YCCI is Yale’s Investigative Medicine Program (IMP), a unique program that offers Ph.D. degrees to M.D. fellows beginning careers in translational or clinical research. The new funding expands the imp and opens the program to nursing, public health, biomedical engineering and biological sciences students. A new CTSA-funded YCCI outpatient facility will add to the clinical studies School of Medicine scientists have conducted at nearby Yale-New Haven Hospital for more than four decades. The YCCI will also form an Office of Community-Based Research and Engagement to build on the strong community ties of the schools of Nursing and Public Health to forge new research partnerships.
Yale’s research “cores,” which give scientists access to state-of-the-art biomedical technologies, are also instrumental to the new effort. The CTSA funding will create a new Office of Research Services within YCCI that will provide clinical investigators with “one-stop shopping” for regulatory, biostatistical, bioinformatics and patient-recruitment services.
“The development of this consortium represents the first systematic change in our approach to clinical research in 50 years,” Zerhouni said in announcing the awards. “Working together, these sites will serve as discovery engines that will improve medical care by applying new scientific advances to real-world practice. We expect to see new approaches reach underserved populations, local community organizations and health care providers to ensure that medical advances are reaching the people who need them.”