Protocol Specific Research Support

新墨西哥大学癌症中心的协议特定研究支持（PSRS）的功能是支持缺乏赞助支持的早期研究者发起的试点研究。早期阶段无支持研究者发起的临床试验由临床工作组提出，并由方案审查委员会（在新墨西哥大学称为医学和科学审查委员会）根据科学价值进行审查。如果它们在这个级别被批准，并且缺乏支持，它们将提交给临床研究委员会考虑机构支持。本次PSRS综述由C. Verschraegen医学博士主持，他是临床研究委员会负责组织PSRS评估的成员。如果不支持的方案被认为值得支持，则将其提交给适当的IRB，如果批准，则由临床方案、数据管理和信息学共享资源实施，并提供方案特定的财务支持。PSRS的研究护士是普雷斯先生，数据管理员是奥尔雷德先生。在2008/ 2009财政年度，有19项研究者发起的i -ll期介入性临床试验需要新墨西哥大学癌症中心的支持。这些试验在2008/9财政年度总计有222名患者。在2008/ 2009财年，有11项研究者发起的I期或I /ll介入性临床试验得到了新墨西哥大学癌症中心的支持。这些试验总共有52名患者。这些试验是创新的试点项目，旨在导致更大的外部支持的后期临床试验。这项重要的新墨西哥大学癌症中心对早期研究人员发起的临床试验的支持表明了一项积极的协议特定研究支持计划。

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.