Moffitt Cancer Center has initiated a major effort to increase the number of investigator-initiated early phase clinical studies. For FY2005, investigators at Moffitt Cancer Center enrolled 490 patients on pilot, phase I or I studies. The Clinical Investigations Program has significantly expanded the phase I effort since the previous submission in 2000. The percentage of subjects enrolled onto Investigator-initiated trials has almost doubled (23% to 44%) over the course of the previous grant period. The proportion of accruals to phase I or I/I I studies remains above 40% of all accruals. The support of innovative phase I and feasibility studies is a clear institutional priority for the coming years of the grant cycle. The scope of this important activity will include outpatient based studies as well as studies conducted for inpatients. Phase I and feasibility studies will take place in both arenas, staffed by research nurses who will supplement the data management core. The maturation of interactions between basic scientists and clinicians, the interprogrammatic working groups, and the establishment of the clinical research unit and translational laboratory support the need for increased numbers of experienced research nursing staff. The institution continues to support the growth of the Phase I Program as demonstrated by the expansion of the Clinical Research Unit in 2001. The current outpatient CRU outpatient area consists of seven treatment rooms (seven beds), 3 infusion area (9 infusion chairs) and three offices, which house five research nurses, two study coordinators, two physician assistants and the Manager of the CRU. Further expansion of this area will be complete in 2007 and will provide additional treatment areas that will expand capacity by at least 60%.
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