PROTOCOL-SPECIFIC RESEARCH SUPPORT In the past year (12/1/2002-11/30/2003), 139 patients were registered on 15 innovative, early-phase investigator-initiated therapeutic clinical trials reflecting the efforts of 8 different OCUCCC principal investigators (Table 2). These therapeutic protocols reflect efforts in four OSUCCC programs; Experimental Therapeutics (ETP), Cancer Control (CC), Molecular Carcinogenesis and Chemoprevention (MCC) and Immunology (IMM). These protocols and patients are managed by the Clinical Trials Office (CTO) utilizing protocol-specific-research nurse support. Based upon the current accrual statistics for investigator-initiated therapeutic clinical trials and an estimate of approximately 35 active participants per clinical research associate or research nurse per year, we can justify a request for 2.4 FTEs for protocol-specific research nurse support in year one of our CCSG renewal (see justification above). The OSUCCC CTO manages 318 trials, including 55 therapeutic trials that were written by local investigators. A number of these (15) are supported though the OSU phase 1 contract (U01 CA76576-03) and 9 others are funded via Quick Trial NIH R21 grants or separate R01s or P01s hence the seemingly low number of innovative phase I studies covered by the Protocol-Specific Research Mechanism is based not on a lack of innovation but rather on innovation rewarded with peer-reviewed funding for clinical research. In addition to those funded through R21s or R01s, investigators have been active in obtaining partial or full support for research efforts through industry partners. The investigators at the OSUCCC are encouraged to actively pursue funding for trials through external peer review mechanisms whenever possible.
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