CLINICAL TRIALS OFFICE

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PROJECT SUMMARY (See instructions): The Clinical Trials Office's (CTO) mission is to support clinical investigators in the development and implementation of clinical research studies at the Moffitt Cancer Center. The infrastructure in place assists the investigators with the following activities: ¿ Assisting investigators in screening and enrolling patients for clinical studies. ¿ Providing data management support for clinical studies. ¿ Assisting the Principal Investigators in the compliant conduct of clinical studies, including assisting in the submission of required regulatory documents, annual reviews and adverse event reporting. ¿ Providing staff training and education pertaining to clinical studies. ¿ Coordinating and implementing protocol related orders for study patients. ¿ Preparing medical and research records for audits. The CTO has seen an average combined accrual to clinical intervention, prevention intervention, and supportive care intervention trials of 2,856 subjects/year for FY's 2006-2010 (an average of 1,176 subjects/year for clinical intervention trials, 780 subjects/year for prevention intervention trials, and 872 subjects/year for supportive care intervention trials). FY 2010 was especially robust, with accruals of 1,287,2,406, and 1,001 subjects to clinical, prevention, and supportive care intervention trials, respectively. The accrual to investigator-initiated trials (external peer reviewed + institutional) for all intervention studies has remained greater than 60% for all 5 years and was 84% in FY 2010. Clearly, these accrual levels, as well as the complexity and increased data collection requirements of current trials, have necessitated growth of the CTO and demand increased efficiency. The CTO operates efficiently for the cost effective management of clinical trials at the Cancer Center. The accrual to all intervention, prevention intervention and supportive care intervention trials continues to increase on a yearly basis. The Core requests CCSG Support of $570,611, which is 13% of its operational budget.