PROTOCOL SPECIFIC RESEARCH SUPPORT

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DESCRIPTION (provided by applicant): 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 Core grant institutional clinical trials support represents an essential funding mechanism for investigator-initiated translational research efforts. Protocol Specific Research Support from the Core grant is critical to development of clinical research and provides funding in multiple situations including early in the development of a concept when preliminary data may be required to obtain extramural peer reviewed funding and initiation of lines of investigation regarded as "high risk" by other mechanisms. 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 Core grant support if he/she does not have a 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 absence of nursing/data management support from the Clinical Protocol and Data Management (CPDM) Facility administrator; the committee review includes a committee recommendation on Core grant 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 14 studies have received funding through this mechanism and these studies have accrued 325 patients (4 year total). This total accrual and accrual/year (81) has exceeded our target by 33% (60 accruals/year). During the next funding period, we will continue to expand our investigator-initiated clinical trials program. With the impressive portfolio of current and completed investigator-initiated trials and our increased number of clinical investigators we expect these investigators will continue to require support from the Core grant to initiate new trials and enhance their ability to compete for extramural funds. Collaboration of clinical investigators with our micro-array laboratory, pharmacology/pharmacokinetics laboratory, imaging resources and pre-clinical scientists will enhance our ability to undertake translational studies with meaningful biologic endpoints. The Hematology-Oncology Unit in The Kirklin Clinic is being expanded from 8,000 to 13,000 ft2. Included is the new outpatient research facility, with its disease-specific and phase I research clinics and will be operational in July 2004.