In the past year (12/1/2008-11/30/2009), 326 patients were registered onto 26 high priority, innovative, feasibility (i.e., pre-phase I, pilot) and phase 1 institutional clinical interventions. These studies reflect the efforts of 19 different OSUCCC principal investigators (Table 2) and the scientific activities of four OSUCCC programs;Experimental Therapeutics (ETP), Cancer Control (CC), Molecular Carcinogenesis and Chemoprevention (MCC) and Immunology (IMM). Patients enrolled onto these protocols are managed by the Clinical Trials Office (CTO) utilizing protocol-specific-clinical research support. Based upon the current accrual statistics for investigator-initiated therapeutic clinical trials and an estimate of approximately 40 active clinical trial participants per clinical coordinator per year, we can justify a request for 5.0 FTEs for protocol-specific clinical support in year one of the CCSG renewal (see justification above). The CTO now manages 365 open clinical trials, including 55 therapeutic trials that were authored by OSUCCC investigators. Clinical investigators at the OSUCCC are encouraged to actively pursue funding for trials through external peer review mechanisms whenever possible. Thus, a number of these investigator-initiated trials (12) are supported though the OSU phase 1 grant (UOl CA76576) or the OSU NOI grant {m^ CM62207). Trials that are not supported by external funds are eligible for Protocol-Specific Research Support.
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