Yale Cancer Center (CCSG)
YCC (CCSG)
Yale Center for Clinical Investigation
(CTSA) YCCI (CTSA)
Director, Yale Comprehensive Cancer Center Thomas Lynch Jr., MD Deputy Director for Administration Kevin Vest
Director, Yale Center for Clinical Investigation Robert Sherwin, MD Chief Operating Officer Tesheia Johnson Associate Director, Clinical Trials Henry Durivage, PharmD
YCCC Clinical Trials Teams
Central Office
YCCI Services
Research Nurses Project Managers Data Managers Clinical Trial Coordinators
IND Support Research IT Regulatory Budgeting Contracts Education & Training
Flexible Staffing Pool Protocol Development Recruitment Clinical Research Spaces Core Laboratory
streamline the approval process and establish training programs for faculty and staff related to clinical trials. There is now a joint quality assurance program, and a new initiative is under way to better organize the management of scientific and safety review committees by integrating support staff. This reorganization reduces the workload of faculty reviews, with the ultimate goal of encouraging increased faculty participation in the review/regulatory process. Besides merging support functions, the two centers have jointly invested in equipment for the Immune Monitoring Core Facility, which supports the work of investigators carrying out clinical trials related to immunologically based diseases, and the Keck Microarray Resource. YCCI and YCC also jointly supported the recruitment of Peter Peduzzi, PhD, to lead the Yale Center for Analytical Sciences ( YCAS ). The center houses a team of biostatisticians, clinical epidemiologists, and health economists to provide biostatistical support services and methodological expertise to investigators. YCCI is one part of an initiative to expand Yale’s informatics infrastructure. Lynch has taken a leading role in exploring the purchase of a clinical trial management system (CTMS) and clinical research data repository ( CRDR ). “Tom’s input has been invaluable as we try to determine the optimal system for integrating these systems in terms of our clinical research needs,” said YCCI director Robert Sherwin, MD, C.N.H. Long Professor of Medicine. YCCI and YCC are joined in other ways as well. The two centers have co-funded a pilot grant to form the Breast Cancer Consortium of Connecticut to focus on increasing access to clinical trials; developing a task force to examine state and national standards for breast cancer treatment; and reducing health disparities through various outreach initiatives. YCCI has also
YCCI and YCC have merged several aspects of their management structure for clinical trials, including joint support of the position of associate director of clinical trials.
worked with the cancer center to launch a statewide clinical trials network to promote innovative cancer research. In the current environment of reduced budgets, decreased funding, and increased regulatory requirements, collaborations that jointly respond to the clinical research needs of different centers are both practical and forwardlooking. According to Sherwin, future plans include expanding this approach as a way to broaden activities for other centers and programs. “There hasn’t been a lot of collaboration between cancer centers and clinical trials centers, so we’re excited that what we’ve put in place so far has been successful,” he said. “Hopefully our efforts will serve as a model for other academic institutions that are interested in both leveraging their resources and conducting innovative research.” The two centers have increased efficiency by sharing the administration and management of protocol review, scientific and safety committees and combining training, education, and auditing activities.
YCCC (CCSG)
Scientific and Accrual Review Prioritization and Monitoring
YCCI (CTSA)
• Committee Management
• Protocol Review Committee (PRC)
• Training
• Clinical Research Steering Committee (CRSC)
• Auditing
• Education
Science, Safety, Special Population and Utilization Review • Science and Safety Committee (SSC) • Pediatric Protocol Review Committee (PPRC)
• Quality Assurance Compliance and Safety Committee (QUACS)
Robert J. Alpern, MD, dean of YSM and Thomas J. Lynch Jr., MD, director of YCC, view the collaboration between the medical school and the cancer center as an ideal partnership. ycci.yale.edu
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