YCCI and the Yale Cancer Center Join Forces to Advance Clinical Research

June 11, 2009

Dean Robert Alpern and Yale Cancer Center Director Tom Lynch standing in front of the new Smilow Cancer Hospital which is slated to open in October 2009.

Bringing new medical treatments from the bench to the bedside requires the pooling of resources and expertise. In order to facilitate this process, YCCI seeks to break down research silos by promoting collaborations among different departments, schools and centers. Partnerships have been created with the Diabetes and Endocrine Research Center, the Program on Aging, the Polycystic Kidney Center, the Liver Center, and the departments of gastroenterology, emergency medicine and anesthesia. YCCI’s earliest and most successful collaboration, however, has been with the Yale Cancer Center. By identifying shared goals and seeking joint funding and resources, this partnership has become mutually beneficial to both centers.

The Yale School of Medicine fully supports this collaboration and has committed to investing in infrastructure and recruiting faculty who are leaders in their fields in order to build upon efforts already underway. “This is an ideal partnership and we’re excited about the progress YCCI and the Cancer Center have made in maximizing resources to ensure that Yale is a premier research institution,” said Robert Alpern, M.D., dean of the Yale School of Medicine and Ensign Professor of Medicine.

Dean Alpern and Dr. Lynch discuss plans for the new Smilow Cancer Hospital.

The partnership between the two centers is well-aligned with the vision of Thomas J. Lynch, Jr., M.D., who was appointed director of the Yale Cancer Center in April. Lynch wants the Cancer Center to be known for discovery and plans on recruiting translational researchers and expanding clinical trials. He believes that Yale is poised to take advantage of its strengths in basic science and that improving the clinical trial structure will increase patients’ access to the newest therapies. This requires an investment in infrastructure, for which YCCI is a logical partner due to its many similar needs. “It’s a wonderful opportunity for us to develop programs and expertise that will jointly benefit both enterprises and ultimately improve patient care,” said Lynch.

The two centers have merged several aspects of the management structure for clinical trials, combining many support functions. This includes joint financial administration of clinical trials for budgeting, contract negotiations, and implementation of systems for billing related to clinical trials; protocol development and IND applications; and supplemental staff for data management and support. There has also been a combined effort in exploring and implementing electronic clinical trial management and data capture systems. YCCI and the Yale Cancer Center have further combined their efforts by working with the Institutional Review Board to 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 underway to better organize the management of scientific and safety review committees by integrating support staff. This will not only be more cost effective, it will also reduce the workload of faculty reviews with the ultimate goal of encouraging more 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 the Cancer Center have also jointly supported the recruitment of a senior faculty leader to oversee and direct the continued expansion of the Biostatistics and Study Design Core, which has a team of biostatisticians, clinical epidemiologists, and health economists that provides biostatistical support services and methodological expertise to investigators.

YCCI and the Yale Cancer Center 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 is also working with the Cancer Center to launch a statewide clinical trials network to promote innovative cancer research.

In the current environment of tight budgets, decreased funding and increased regulatory requirements, collaborations that jointly respond to the clinical research needs of different centers are both practical and forward-thinking. According to YCCI Director Robert Sherwin, M.D., C.N.H. Long Professor of Medicine, future plans include expanding this approach as a way of broadening activities for YCCI’s cores, such as biostatistics and bioinformatics, and working with Yale-New Haven Hospital to augment nursing capabilities for inpatient studies. “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.”