The overall goals of the Protocol Specific Research Support are to promote the conduct of novel therapeutic trials by Cancer Center Faculty and to provide research nursing and data management support for high priority Cancer Center investigator-initiated clinical trials that lack extramural support. The CCSG institutional clinical trials support represents an essential funding mechanism for investigator-initiated translational research efforts. When protocols written by Cancer Center members are submitted to the Protocol Review and Monitoring System (PRMS) Committee, the investigator has the option to request CCSG support if he/she does not have an adequate source of funds to provide nursing and data management and he/she feels that the trial has high scientific merit. Prior to the PRMS Committee meeting, the Chairman of the Committee confirms the insufficient nursing/data management support from the Clinical Protocol and Data Management (CPDM) Shared Facility administrator;the committee review includes a committee recommendation on CCSG support to the Center Director. The criteria used include high scientific merit (<2.0 on a 1-5 scoring system), translational nature of the study and a priority area of the Cancer Center's PRMS Committee review. The final approval on such trials rests with the Center Director. Since the last funding period 13 studies have received funding through this mechanism and these studies have accrual of 283 patients. During the next funding period, we will continue to support our investigator-initiated clinical trials program. We have identified faculty slots for three additional clinical trialists in the Division of Hematology-Oncology and at least one faculty slot in the Department of Surgery to expand our investigator-initiated clinical trial portfolio. Collaboration of clinical investigators with our new shared facilities and the pre-clinical scientists will enhance our ability to undertake translational studies with meaningful biologic endpoints.
Support for new ideas at the earliest stages is critical to development of clinical research. Protocol Specific Research Support provides funding early in the development of a concept when preliminary data may be required to prove feasibility needed to extramural peer reviewed funding and/or initiation of pilot phase 11 trials. This support also allows demonstration of feasibility and preliminary anti-tumor efficacy for trials considered high risk by other mechanisms.
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