The overwhelming majority of patient accrual to City of Hope (COH)-sponsored trials without other sources of peer-reviewed support was to Phase l/ll and pilot trials by COM clinical investigators. This was made possible by the protocol specific research support (PSRS) of the CCSG. This resource has played an important role in providing preliminary data for new R01 and P01 proposals. These protocols all are subject to review by the Clinical Protocol Review and Monitoring Committee (CPRMC), as described under the PRMS section. Funding for the PSRS staff will provide the Cancer Center with a stable core of expert staff who are highly qualified to support the conduct and completion of innovative, short-term feasibility studies originating from COHCCC Programs. The studies supported by PSRS are the foundation of the programs in Hematologic Malignancies, Developmental Cancer Therapeutics and Cancer Immunotherapeutics. More than 500 patients per year were accrued to therapeutic clinical trials by these three programs over the last grant cycle;in FY 2006 this accrual grew to 652 patients enrolled on therapeutic trials. Accrual to investigator-initiated, COH-sponsored trials (without other peer-reviewed sources of support) comprised 34% of the patient volume enrolled onto interventional trials in FY 2006. The prioritization of the usage of the resources provided by PSRS (and the oversight of the budget) is performed initially within the clinical research programs themselves and then by the review provided by the Clinical Research Governance Board, chaired by Dr. Robert Figlin. Oversight of the CRAs involved in these trials occurs at several levels including that provided by the clinical research program leaders, the protocol Principal Investigators, and by the Clinical Protocol Management Core (CPMC) training and quality assurance process. All of the CRAs requested in support of protocol specific research from the CCSG are part of the larger, centralized pool of CRAs overseen and administered by the CPMC. Funding is requested to support three full-time equivalents (FTEs) spread over 6 CRAs to cover the broad spectrum of trials and programs, while allowing diseasespecific focus for protocol management of funded trials as well. These CRAs are responsible for protocol monitoring, data collection and data quality control for our in-house Phase I and pilot studies. They help ensure the success of the clinical studies by providing eligibility checks of patients prior to enrollment, assisting in meeting accrual goals, providing follow-up and recording accurate complete subject data.
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