The Protocol Specific Research Support (PSRS) of the UNM Cancer Center functions to support early phase investigator-initiated pilot studies that lack sponsored support. Early phase unsupported investigator-initiated clinical trials are proposed at the Clinical Working Group level, and reviewed by the Protocol Review Committee (at UNM termed the Medical and Scientific Review Committee) for scientific merit. Should they be approved at this level, and lack support, they are submitted to the Clinical Research Committee for consideration of institutional support. This PSRS review is chaired by C. Verschraegen, MD, the member of the Clinical Research Committee responsible for organizing PSRS evaluations. Should the unsupported protocols be deemed worthy of support, they are then submitted to an appropriate IRB, and if approved, implemented by the Clinical Protocol, Data Management, and Informatics Shared Resource with protocol specific financial support. The PSRS research nurse is M. Pruess, and the data manager is M. Allred. In FY 2008/9 there were 19 investigator-initiated Phase l-lll interventional clinical trials that required UNM Cancer Center support. These trials accrued 222 total patients in the FY 2008/9. In FY 2008/9 there were 11 investigator-initiated phase I or l/ll interventional clinical trials that were supported by the UNM Cancer Center. These trials accrued 52 total patients. These trials were innovative pilot projects that were designed to lead to larger externally supported later phase clinical trials. This significant UNM Cancer Center support of early phase investigator-initiated clinical trials demonstrates an active Protocol Specific Research Support program.

Public Health Relevance

Developing effective new cancer therapies is important since the survival of many patients with cancer is still poor. Not all new therapies are financially supported, especially those developed individually by UNM Cancer Center clinical investigators. The Protocol Specific Research support mechanism provides support for new cancer treatments that have no other financial support. This increases the number of new treatments that can be tested here.

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Subcommittee G - Education (NCI)
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