New Haven, Conn.--As part of a major national initiative to speed research from the laboratory bench to patients in need, Yale School of Medicine Tuesday received a $57.3 million Clinical and Translational Science Award (CTSA) from the National Institutes of Health (NIH).
The funding includes $31.5 million in new resources that will greatly strengthen clinical research at Yale and $25.8 million to continue existing programs in education and the activities of the General Clinical Research Center at nearby Yale-New Haven Hospital, where medical school scientists have carried out clinical research since the 1960s. Key participants include the Yale School of Nursing, the Department of Epidemiology & Public Health, the Department of Biomedical Engineering, and the Combined Program in the Biological and Biomedical Sciences.
The CTSA initiative is a new program instituted by NIH Director Elias Zerhouni, M.D., as part of the NIH Roadmap for Medical Research. The goal is to transform how biomedical researchers move laboratory discoveries into human studies, ultimately enabling faster and more efficient development of new therapies.
Eleven other academic medical centers across the nation also received CTSAs. When fully implemented in 2012, the initiative is expected to provide $500 million annually to 60 academic health centers working in concert.
"The development of this consortium represents the first systematic change in our approach to clinical research in 50 years," said Zerhouni. "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."
According to Robert Alpern, M.D., dean of the medical school, Yale is ideally positioned to fulfill the mission of the CTSAs. "A strategic planning initiative we launched in 2004 identified clinical research as a top priority and established the Yale Center for Clinical Investigation (YCCI), a focal point for translational research," Alpern said. "The YCCI's structure, which builds 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."
Yale will use the unprecedented grant to train a new generation of investigators in interdisciplinary clinical research, stimulate the extension of research from the laboratory to bedside, launch greater numbers of Phase 1 studies of drugs discovered by Yale scientists, and forge research relationships with the local community to improve public health.
The educational centerpiece of the YCCI is Yale's Investigative Medicine Program, a unique doctoral program that offers Ph.D. degrees to highly qualified M.D. fellows embarking on careers in translational or clinical research.
Robert Sherwin, M.D., YCCI director and principal investigator on the CTSA grant, says that studies with human subjects are exceedingly complex because they require combined expertise in basic science, clinical medicine, nursing, statistics, and regulatory issues.
"With the CTSA grant we will be able to train many more clinical investigators, known as YCCI Scholars, who will be well-equipped to assemble the expert interdisciplinary teams they need to do top-quality translational research," Sherwin said.
Yale's research "cores," which provide scientists with state-of-the-art biomedical technologies, are also instrumental to the new effort. "Many of our basic science researchers believe that a new emphasis on clinical translation is very much needed," Alpern said, "and Yale has the facilities to handle very large databases in biostatistics, bioinformatics, genomics and proteomics." The CTSA funding will create a new Office of Research Services at Yale, a component of YCCI that will provide clinical investigators with "one-stop shopping" for regulatory, biostatistics, bioinformatics, recruitment and other support services.
In addition a new CTSA-funded Office of Community-Based Research and Engagement, also a part of YCCI, will build on the strong community ties of the Yale School of Nursing and the Department of Epidemiology & Public Health to forge new research partnerships to improve public health.
The CTSA initiative grew out of the NIH commitment to re-engineer the clinical research enterprise, one of the key objectives of the NIH Roadmap. The CTSA consortium will be led by the National Center for Research Resources (NCRR), a part of the NIH. Funding for the CTSA initiative comes from redirecting existing clinical and translational programs, including Roadmap funds.
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