Purpose: To support the conduct of high quality innovative feasibility and phase I clinical research protocols. Services: Evaluate and prioritize innovative clinical research concepts; recruit study participants; collect, edit and enter patient data into the computer. Justification: Assessing the feasibility of prevention, diagnosis, and treatment trials often requires the analysis of preliminary data to determine the logistic feasibility and safety of the protocol and treatment. Information gained from the trials promotes the development of phase II trials and generates preliminary data for subsequent grant proposals. Table 1 demonstrates the protocols supported entirely or in part by the PSRS during the previous grant period. 60 protocols were supported from 1999-2002. At the end of 2002, 26 trials were in development as noted in Table 2. As noted by bold type in Table 1, 10 studies have resulted in follow up phase I or II trials either active or in development. The three studies identified by asterisks in Table 1 have resulted in extramural funding or grant proposals. For example, 98-01-12 led to a phase II trial in the North Central Cancer Treatment Group to assess the efficacy of this combination in non-Hodgkin's lymphoma. Dr. Steven Ansell has secured R01 funding to support laboratory components of the trial. Protocol 99-01-02 provided preliminary data leading to a trial in development for ovarian carcinoma and support of Dr. Charles Erlichman's project in a submitted ovarian SPORE application. Organization: Each concept to be considered for Protocol Specific Research Support is reviewed by the disease or discipline oriented group for scientific merit and consistency with the scientific aims of the particular group. A statistician must review the proposed concept and collaborates on study design. Subsequently, the concept is reviewed by the Cancer Center Support Concept Review Committee (Table 3) that meets every other week.
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