The Clinical Protocol Office (CPO) is a UNC Lineberger shared resource that is widely used by members from various disciplines to perform translational and clinical research using patient populations at the Center and its affiliates. The CPO has centralized the protocol registration and management of all institutional clinical trials at UNC into a single office. Dr. Thomas Shea is the Faculty Director and Libby Anderson, R.N., M.Ed., protocol activities; provide resources to individual investigators to facilitate approval of UNC/LCCC sponsored clinical research; and oversee the conduct of cancer clinical trials at UNC. The CPO also now offers coordination services for multi-center studies including study initiation activities, planning of investigator meetings, regulatory documents management, case report management, case report form development, multi-center data coordination and clinical research monitoring. The existing staff of 23 supports 258 active trials with approximately 400 protocol patients currently being treated. In addition, through the Biostatistics Core Facility, the CPO has the services of biostatisticians (Michael Schell, Ph.D., Bahjat Qaqish, M.D., Ph.D., and two Masters- level biostatisticians) who provide input in the maintenance of the Cancer Center database and expertise in the design of clinical studies. Approximately 1,039 protocol patients are managed for follow-up by current staff. In 1998, the CPO assisted in the initiation of 92 new protocols. The activity of the Clinical Protocol Office continues to increase. Accrual to treatment protocols has increased from 188 in 1993 to 347 in 1998. UNC patient accrual to all trials totaled 474 in 1998. Over 300 additional patients (311) were enrolled through the UNC affiliate network, resulting in a total of 785 patients enrolled onto clinical trials under the auspices of the UNC LCCC. Patient accrual to institutional treatment trials has increased almost three fold in the last five years, rising from 66 in 19993 to 190 in 1998. Minority accrual to all trials has remained steady at approximately 27 percent (annual range 20-33%). In 1998, a total of 43 Cancer Center members used the Clinical Protocol Office to open, amend, or renew a protocol, or take some other action. The 43 members, plus 10 additional non members, accounted for 581 actions, with Center members accounting for 567 (97%) actions. The non- member activity was generated by fellows or faculty working on collaborative projects with Center members. The UNC Lineberger Clinical Protocol Office is the focal point for development and initial of clinical cancer trials at UNC. During the last four years, new leadership has been put in place, substantial institutional resources have been committed, and the clinical research program has grown significantly. Continued expansion of the CPO will be necessary during the next five years as the Center, the School of Medicine, and the UNC Hospitals continue their emphasis on clinical research and oncology. Several projects intended to meet these needs are under way including improvement of the Web site for the Protocol Office to provide information regarding ongoing studies, updating or existing clinical trials management databases, and development of a formalized network of clinical trial sites for participation in institutional trials coordinated by the UNC CPO. These are a few examples of how the Clinical Protocol Office continues to seek new ways of meeting the needs of the Cancer Center members and protocol patients it serves.

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