Protocol Specific Research Support

协议特定研究支持

• 批准号: 8180663
• 负责人: Claire F. Verschraegen
• 金额: $ 6.3万
• 依托单位: UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8180663
• 关键词: Back; Cancer Center; Charge; Clinical; Clinical Investigator; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Communities; Data; Data Collection; Ensure; Evaluation; Financial Support; Foundations; Funding; Gifts; Goals; Individual; Informatics; Laboratories; Lead; Malignant Neoplasms; Measures; Medical; Monitor; New Mexico; Nursing Research; Oncologist; Patient Care; Patients; Peer Review; Phase; Physician Executives; Pilot Projects; Process; Productivity; Protocols documentation; Research Activity; Research Ethics Committees; Research Personnel; Research Support; Resources; Review Committee; System; Taxes; Testing; Tobacco; Translational Research; Universities; base; cancer care; cancer therapy; data management; design; informatics shared resource; innovation; meetings; member; prevent; programs; tumor; working group

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.

UNM癌症中心功能的方案特定研究支持（PSRS）支持没有赞助支持的早期研究者发起的试点研究。早期阶段不支持研究者发起的临床试验在临床工作组层面提出，并由协议审查委员会（UNM指定的医学和科学审查委员会）进行审查，以供科学功绩进行审查。如果他们在此级别批准并缺乏支持，则将其提交给临床研究委员会以考虑机构支持。该PSRS审查由负责组织PSRS评估的临床研究委员会成员C. Verschraegen主持。如果不支持的协议被认为值得支持，则将其提交给适当的IRB，如果获得临床协议，数据管理和Informatics Informatics共享资源的批准，并具有特定于协议的财务支持。 PSRS研究护士是M. Pruess，数据经理是M. Allred。在2008/9财年，有19个研究者发入的L-LLL介入临床试验需要UNC癌症中心支持。这些试验在2008/9财年累计222例患者。在2008/9财年，有11期研究员发入的I期或LL/LL介入临床试验得到了UNM癌症中心的支持。这些试验累积了52例患者。这些试验是创新的试点项目，旨在导致更大的外部支持后期临床试验。早期研究者发起的临床试验的这一重要的联合国癌症中心支持表明了一项主动方案特定的研究支持计划。