Major support for clinical/translational research is renewed

Yale School of Medicine has been awarded nearly $63.7 million over the next five years from the National Center for Advancing Translational Sciences (NCATS) to renew its five-year Clinical and Translational Science Award (CTSA) to accelerate research discoveries that can have a positive impact on health.

This is the third renewal for Yale, which was the only site in New England among the first 12 insti- tutions to receive CTSA funding in 2006, when the National Institutes of Health started the program. The award supports the Yale Center for Clinical Investigation (YCCI),

Established in 2005 as part of YSM’s strategic plan to develop an infra- structure to better support translational and clinical research and to comprehensively educate the next generation of these investigators. YCCI also receives support from YSM and Yale Medicine, as well as Yale New Haven Health System, which includes Yale New Haven Hospital, one of the nation’s largest hospitals, and a network of five other hospitals and more than 300 practice sites.

“Support from the CTSA has allowed YCCI to innovate, to facilitate clinical and translational research that has had a national impact, and to develop the next generation of investigators,” said Nancy J. Brown, MD, Jean and David W. Wallace Dean of Medicine and C.N.H. Long Professor of Internal Medicine. “Continued support for the next five years will enable YCCI to enhance the resources available to investigators and make clinical research more accessible to all patients.”

Yale is one of the largest CTSA-funded hubs from what is now a consortium of more than 50 such hubs across the country. NCATS supports this network to expand and improve the process that turns laboratory discoveries into treatments. NCATS fosters efficiency and innovation at CTSA hubs and encourages institutions to work together. The idea is to harness strengths that can be shared across the CTSA Consortium to accomplish objectives as a group that no single site could do on its own. As a consortium member, Yale may apply for additional funding to launch new initiatives that is available exclusively to CTSA hubs, including administrative supplements, collaborative grants, and exploratory/developmental grants.

Under the new five-year award, YCCI will follow three over-arching themes. It will expand the scale and rigor of clinical research by strengthening the “learning health care system” and enhancing the bioinformatic and computational research infrastructure across Yale and Yale New Haven Health. New initiatives harness ever-increasing amounts of digital health data, with real-time visualization of actionable knowledge for clinicians, patients, and other stakeholders, to transform the health care system into one that rapidly learns and continuously improves local practices and guides health care nationally. A primary tool is the direct engagement of patients through the patient portal MyChart, which contains patients’ electronic health records. Not only are all studies listed by disease category, but patients can express interest in an active study or sign up for direct alerts of future studies through the same portal they use for scheduling their clinical appointments.

It also will bring the benefits of precision medicine to meet the needs of diverse communities through developing “personalized health.” For example, the “One Heart Initiative,” developing in partnership with the YCCI Cultural Ambassadors, will accelerate the early identification of treatable, but hard to recognize, cardiac disorders in greater New Haven and southern New England communities through mechanisms such as novel point of care testing strategies in places such as community health fairs.

Addressing health care disparities is the third priority. YCCI will initiate a comprehensive program that will involve local communities of color in an array of clinical trials to capture those communities’ specific treatment needs, as well as the imperative to increase diversity in Yale’s health care and research workforce. For more than a decade, YCCI’s Cultural Ambassadors program has been a national model for engaging local communities in clinical research. Community leaders, especially representatives from the AME Zion Church and the Latino organization Junta for Progressive Action, have encouraged participation by the community in clinical research by explaining its benefits, and in turn guided Yale’s approach by advising on best methods to relate to community members. This process will further expand and become even more robust over the next five years.

Educating tomorrow’s leading clinician scientists is also a top priority under the CTSA. YCCI has identified a diverse group of talented trainees, fellows, and junior faculty embarking on careers in translational and clinical research and provided them with the best possible tools and training, including hands-on experience in working collaboratively as part of multidisciplinary teams. Scholars and trainees are drawn from a range of disciplines across Yale’s Schools of Medicine, Nursing, Public Health, and Management, the Graduate School of Arts and Sciences, the Department of Biomedical Engineering at the School of Engineering and Applied Science, and Yale Law School. Since 2006, 151 past or current Junior Faculty Scholars have received more than $557 million in independent grant funding. YCCI’s educational offerings include the Investigative Medicine Program, which awards a PhD in investigative medicine to physicians, and the National Clinician Scholars Program, a fellowship program for clinician leaders to improve health and health care.

YCCI has developed 33 new programs and strategic initiatives that did not exist prior to funding by the CTSA. It also has made major investments that have expanded or enhanced existing resources of 22 additional programs that span the university.

YCCI’s co-directors are John Krystal, MD, Robert L. McNeil Jr. Professor of Translational Research, professor of psychiatry, of neuroscience, and of psychology, and chair of psychiatry; and Brian R. Smith, MD, chair and professor of laboratory medicine, professor of biomedical engineering, of medicine, and of pediatrics, and deputy dean for research (clinical and translational).

Over the next five years of CTSA funding, the goals of YCCI will include:

• To strengthen and further build institutional infrastructure to foster translational research. This will accelerate translational research—from the laboratory to the bedside to populations—through advancing technology, improving access to data resources, and creating an expanded array of supports (administrative, regulatory, bioethical, methodological, biostatistical, and recruitment assistance).
• To develop and support a diverse cadre of early career translational scientists and all members of the translational workforce enterprise, within an environment that promotes team science. We will attract the most talented staff, trainees, and faculty; to train them in translational research; to support their engagement in multidisciplinary research teams; and to provide fellows and faculty with funding to support research training, conduct pilot studies, and access to research cores.
• To advance engagement of our CTSA with local stakeholders and implement novel methodologies and resources to address the needs of special populations within our catchment area. We are forging new connections with our broad surrounding community so that our CTSA research better engages them and serves their needs.
• To expand collaborations between our CTSA, the National CTSA Network, and other stakeholders in the research enterprise. We will continue to expand our collaborations with other CTSA Network Hubs and other entities (FDA, HHS, industry, VA Healthcare, international partners) to broaden the dissemination of our research data and best practices. We also propose to initiate a broad new role as a coordinating center for Yale-led multi-center academic trials, and to increase the engagement of Yale investigators in NIH- and industry-supported multi-center initiatives.