Protocol-Specific Research Support (PSRS) Innovative clinical research that involves early phase, investigator-initiated therapeutic trials or clinical trials emanating from the research activities of members of the University of Maryland Marlene and Stewart Greenebaum Cancer Center (LJMGCC) frequently requires funding to support research coordination, data management, and regulatory functions. Even when research grants provide partial funding or when drug supplies are provided free from commercial parties, additional support is necessary to move such trials forward, especially because per-patient costs are not reimbursed. PSRS will support research coordinators and data managers at UMGCC to facilitate these innovative clinical investigation efforts. Trials supported by PSRS will be subject to additional criteria for consideration by the Clinical Research Committee. The trials will be assigned a priority scale for funding based on (a) what innovation within the proposed PSRS-directed protocol will contribute to achieving a novel cancer diagnosis, treatment, imaging, or prevention strategy; (b) how critical correlative science will be enabled as a result of PSRS funding;and (c) what independent funding applications will emerge from the PSRS-supported trial. Twenty-four therapeutic protocols in UMGCC's portfolio and at least four new trials under development potentially qualify for this type of support. Accordingly, we are requesting PSRS of 25 percent each for two research coordinators and two data managers. This support will give UMGCC the flexibility to advance the cause of high-priority, innovative, early phase clinical trials. These trials will flow from investigator-initiated clinical research or will 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 cooperative-group trials of the National Cancer Institute or industry-sponsored trials.
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