There are currently three Clinical Research Nurse FTEs supported by Protocol-Specific Research Support. These nurses support NIH funded PI Initiated clinical research programs conducting high volume, and complex, translational early phase clinical research: Neuro-oncology, BMT, Experimental Therapeutics, GYN Oncology, Radiation Oncology, GU Oncology, Thoracic Oncology and Breast and Ovarian Cancer. All of the studies which qualify for support are reviewed and discussed at the DCCC Executive Committee. After receiving PRMS approval, and review by the Director of the Clinical Trial Shared Resource, the level of support for each trial is assigned. This support Is usually distributed to the programs pursuing pilot and Phase I studies for which external funding does not exist or is inadequate. Decisions are also influenced by innovation, feasibility, and priority of the project. These funds support Individual clinical research nurses and data managers providing salary support by percent effort. As investigative programs acquire external funding support or as new needs develop for clinical investigators, the funding for these positions Is redistributed. The process for awarding this supports starts with the Scientific Priority Score assigned by the Cancer Protocol Committee at initial review. This score is conveyed to the Disease Site Program Director and Principal Investigator as well as the Clinical Trials Office. The Director of the Clinical Trials Office then meets with the PI of the project to discuss the support needed and guidelines for the use of any supplied support (i.e. support must be used for a research nurse or data manager). All studies which qualify for support are discussed and voted on at the DCCC Executive Committee. Decisions are based by priority score, innovation, feasibility, other possible resources for support, duration and patient accrual. All projects are early pilot or Initial phase testing of an agent or device for the diagnosis, prevention, detection or treatment of cancer. All of these clinical trials are reviewed for scientific progress at the time of full audit and through the annual scientific reviews by the Scientific Monitoring Subcommittee. This group is also charged with closing studies which do not meet accrual goals within appropriate time metrics. The Clinical Trials Protocol Office monitors the effort of staff receiving support through this Shared Resource and reports to the Director of the Clinical Trials Shared Resource and the Director of the DCCC on this status quarterly. Duke University School of Medicine and Health System has and continues to make a significant commitment to oncology clinical research. Duke supports clinical trials review, independent monitoring and safety desk. Oncology will play a key role in Duke's future plans. Including the building of a cancer treatment building and recruitment of new faculty. In addition, with the centralization of services through the clinical trials office the disease site program leaders will have funding to mentor and support PI initiated clinical trials, especially for new investigators. The DCCC Clinical Trials Office, with the guidance of the Director of the DCCC and the Director of the Clinic Trials Shared Resource, has put in place mechanisms to provide quality assurance that the funds are appropriately dispersed and utilized. Given these events, especially Duke's commitment to support oncology clinical trials, we feel there will be a significant Increase In the number of PI Initiated innovative clinical trials. As these trials would greatly benefit from nursing and data management support and we are requesting one additional FTE to facilitate the operation and conduct of these trials.
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