Dean Robert Alpern, Thomas J. Lynch, M.D., and Robert Sherwin, M.D., discuss strategies to meet Yale’s clinical and translational needs.
The Yale Center for Clinical Investigation (YCCI) has had a history of collaboration from its inception. This approach began during the planning stages of the Clinical and Translational Science Awards (CTSA) application and has led to the integration and growth of a number of programs and centers. Along the way, many useful synergies have been discovered; resources have been more effectively utilized; and exciting new cross-institutional and interdisciplinary programs have been introduced that are having a major impact on clinical and translational research and training at Yale.
The collaboration between YCCI and the Yale Cancer Center is an example of the benefits of a collaborative approach. Identifying shared goals and seeking joint funding and resources has solidified a partnership that has become beneficial to both centers. “I’m incredibly pleased with our collaboration with YCCI, and I believe that selectively applying this strategy to areas where we have common ground has been very effective,” said Thomas J. Lynch, M.D., director of the Cancer Center. “These kinds of partnerships and proposals are critical in managing our institutional and NIH resources.”
While interaction between cancer centers and CTSA sites was discouraged at one time, that is no longer the case.“We’re now expected to work together for mutual benefit,” noted Beverly Ginsburg Cooper, M.B.A., senior vice president for research at Dana-Farber Cancer Institute.
The joint effort at Yale has allowed both centers to leverage resources and strengths to achieve noteworthy results. For example, recognizing the need to develop a center for biostatistics support, YCCI, the Cancer Center and the School of Public Health together support the Yale Center for Analytical Sciences (YCAS); they collaborated on the search that culminated in the recruitment of Peter Peduzzi, Ph.D., to lead it. YCAS serves as a clearinghouse for a steadily growing number of biostatistics faculty members, providing support for study design and biostatistical analysis to investigators across the medical campus. The Center has both CTSA-supported resources and dedicated cancer resources, due to the high demand from Cancer Center members.
The support of research cores, which requires the investment of millions of dollars to purchase, maintain and repair sophisticated instrumentation, is another area where the two centers have collaborated. It is much more cost-effective for YCCI and the Cancer Center to jointly shoulder the high costs of these resources, which are available to all investigators, than to maintain separate facilities. For example, the two centers jointly supported the expansion of the Flow Cytometry core, which has multiple applications in cancer research. Originally this resource supported only animal studies, but the collaboration has allowed for expanding it to include human samples. Genomics is another area where it makes sense to leverage resources. The Cancer Center and YCCI collaborated to provide funding for equipment and faculty expertise in bioinformatics and biostatistics for the Yale Center for Genome Analysis, which generates massive amounts of data.
Yale’s IT overhaul, which includes the implementation of Epic and OnCore, a clinical research management system, has also been supported by both centers. Lynch was co-leader of the search for OnCore and was instrumental in ensuring that it would be integrated with Epic and that it would meet the needs of the entire clinical and translational research enterprise. The implementation began with the Cancer Center in preparation for the pending CCSG review and is expected to be complete by mid-February, when the hospital’s Epic-Go Live will take place.
In order to provide the robust infrastructure necessary to conduct clinical and translational research effectively, YCCI and the Cancer Center merged several components of their management structures, including joint financial administration of clinical trials for budgeting; the implementation of systems related to the billing of clinical trials; IND support and development applications; and identifying supplemental staff for data management and support. The two centers also jointly recruited leaders and staff to support these centralized functions and have joined forces to offer staff training on research-related topics. “With both centers committed to working together, I believe the opportunities are endless,” said Lynch.
YCCI has also collaborated with the Department of Psychiatry in several areas. Investigators from the department regularly utilize the Hospital Research Unit, while YCCI funds a research nursing position that provides infrastructure for all research conducted in the department. The research nurse works at a number of facilities, including the VA Connecticut Healthcare System, the Connecticut Mental Health Center (CMHC), the PET Center, the Clinical Neuroscience Research Unit (CNRU), and the Hospital Research Unit.
“Having a centralized person that can cross institutional boundaries makes it a flexible resource and also offers the unique opportunity of seeing how work is done at different facilities,” said Robert Malison, M.D., professor of psychiatry and director of the CNRU. For example, YCCI-funded nursing support was instrumental in developing a research infrastructure for ketamine infusion studies conducted by Gerard Sanacora, M.D., Ph.D., professor of psychiatry, which are paving the way to developing new treatments for depression.
While senior investigators in psychiatry have benefited from the research nurse position, it has been a tremendous asset to junior investigators, who may lack the resources to run complex studies. “Young investigators bring enormous creativity, intelligence, talent and hard work to the table but all of that would be like seeds in a desert soil without the kind of field created by YCCI,” said Malison.
YCCI has expanded and transformed clinical and translational research training at Yale through its support of existing programs and the creation of new ones. The YCCI Scholars program supports training for the next generation of clinical and translational investigators in departments across all three health schools. Since its inception in 2006, the program has awarded salary and research support to 77 investigators, who in turn have generated $118 million in independent funding and published over 579 papers. Faculty members from many departments on the medical campus participate in the Scholars mentoring program and are also active in YCCI’s other training programs, serving as mentors to TL1 students and on the thesis committees of students in the Investigative Medicine Program.
YCCI has also invested in and collaborated with the NIDDK-funded Yale Diabetes Research Center (DRC), helping to create the Center’s Translational Core; supporting a specialized research nurse to assist with complex metabolic studies; and supporting structured training and credentialing for new investigators and research nursing staff for metabolic research techniques.
“Research today is a complex and costly enterprise due to the nature of the problems we need to tackle,” said Malison. “It’s not possible for one person in one group; it needs to involve multiple individuals with multiple expertise doing multimodality research using a convergence of methodologies.” Collaborating with other centers allows these types of interactions to take place and benefits Yale’s entire research enterprise.