Protocol Specific Research Support

新墨西哥州大学癌症中心的议定书特定研究支持(PSR)的职能是支持缺乏赞助支持的早期研究人员发起的先导研究。由研究人员发起的早期阶段临床试验是在临床工作组一级提出的，并由议定书审查委员会(在新墨西哥州大学称为医学和科学审查委员会)对其科学价值进行审查。如果他们在这一级别获得批准，并且缺乏支持，他们将被提交给临床研究委员会，以考虑机构支持。本次PSRS评审由C.Verschraegen医学博士主持，他是负责组织PSRS评估的临床研究委员会成员。如果不支持的协议被认为值得支持，则将它们提交给适当的IRB，如果获得批准，则由临床协议、数据管理和信息学共享资源实施，并提供协议特定的财务支持。PSRS研究护士是M.Pruess，数据经理是M.Allred。在2008/2009财年，有19项由研究人员发起的L期介入临床试验需要UNM癌症中心的支持。在2008/2009财年，共有222名患者参加了这些试验。在2008/2009财年，有11项由研究人员发起的I期或L/11期介入临床试验得到了新墨西哥州大学癌症中心的支持。这些试验共收集了52名患者。这些试验是创新的试点项目，旨在导致更大规模的外部支持的后期临床试验。UNM癌症中心对早期研究人员发起的临床试验的这一重大支持表明，有一个积极的议定书特定研究支持计划。

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.