Protocol Specific Research

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PROJECT SUMMARY (See instructions): Protocol-Specific Research Support (PSRS) Innovative clinical research, especially that tied to UMGCC basic research and involving pilot or pre Phase I, or Phase I investigator-initiated trials testing clinical interventions with a candidate agent or device for the diagnosis, prevention, detection, or treatment of cancer may be eligible for Protocol Specific Research Support (PSRS). Such support will underwrite research coordinator activities and data management functions. Data from such research protocols can be used to support later phase activities with these interventions, or as a basis for acquiring funding from other sources to continue the piloted activities. This critical early support provided by PSRS, is necessary to move such trials forward, especially because per patient costs are not reimbursed. PSRS, utilizing recently revised (2008) guidelines from the National Cancer Institute (NCI) for its use, will support research coordinators and data managers at UMGCC to facilitate these innovative clinical investigation efforts. Trials supported by PSRS will be approved for such funding only after meeting additional criteria as judged by the Clinical Research Committee. The trials will be assigned a priority scale for funding based on how the protocol is, respectively, significant and innovative in promoting the development of a novel cancer diagnosis, treatment, imaging, or prevention strategy. Additional criteria include evidence that the proposed trial possesses correlative science that will be critically enabled as a result of PSRS funding, with translational collaborators and assays in place, and the use of PSRS funding will allow the development of independent or future funding vehicles for the research strategy. Five of 22 recently (CY2009) approved investigator-initiated trials in UMGCC's portfolio potentially qualify for the up to 1 year of research nurse and data manager support in accord with the new PSRS guidelines limiting the type of use and period of applicable PSRS funding. This support will give UMGCC the flexibility to advance the cause of high-priority, innovative, early phase clinical trials. These trials will have no or at best partial industry support, excluding per-patient costs. Ideally, PSRS-supported studies would flow from investigator initiated clinical research, or would be the logical consequence of an alliance between basic scientists at UMGCC and clinicians who are suitable for addressing a translational science goal that is not incorporated into other grant-supported trials of NCI or other funding agencies.