Shared Resources-Clinical Research Services

点击翻译按钮获取中文摘要

The Clinical Trials Office has grown substantially during the current project period, in terms of number of clinical investigators served, the number of investigator-initiated studies and the support personnel who enable clinical trials at the Yale Cancer Center (YCC). To meet the growing needs of the investigators and YCC's mission of promoting translational and clinical research, the Clinical Trials Office has been restructured and renamed the Clinical Research Services (CRS). The CRS is a YCC Shared Resource that provides centralized management of all clinical trials conducted at the YCC. It provides support for the development, implementation, and management of human-investigational studies with a particular focus on developing and managing early phase investigator-initiated studies. To meet these objectives, the GRS has been re-organized into five distinct and specialized support units with dedicated personnel (protocol development, budgets and contracts, data management, investigational new drugs, and clinical research nursing) to provide an integrated, highly coordinated set of resources that can efficiently and effectively support the conduct of clinical studies. This resource provides the infrastructure necessary to support translational research and high-quality clinical trials. The CRS is directed by Dr. W. Kevin Kelly, whose knowledge, experience, expertise, leadership and managerial skills make him particularly well qualified to serve as CRS Director. The CRS interacts closely with other YCC Shared Resources, especially Biostatistics and Biomedical Informatics, to facilitate protocol design, development, and monitoring. The CRS also works closely with the YCC Office of Protocol Review and Monitoring in implementing quality control and assurance measures as well as identifying areas of need for training and education that lead to improvement of operations. In addition, the CRS ensures compliance with the YCC Data and Safety Monitoring Plan. At the time of this submission, 48 clinical therapeutic protocols are open and monitored by the CRS (31% investigator-initiated; 35% industry-sponsored; 33% cooperative group). The number of new trials activated in 2006 was 14, of which 5 were investigator-initiated. As the number of YCC clinical investigators has increased along with growth of oncology faculty, numbers of patients, and number of active studies, the usage of the CRS has increased significantly. The CRS is structured and directed in a manner that efficiently facilitates the conduct of innovative, investigator-initiated clinical trials.