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癌症中心的方案特定研究支持（PSRS）的功能是支持缺乏赞助支持的早期阶段由制药商发起的试点研究。在临床工作组层面提出早期阶段无支持的药物启动的临床试验，并由方案审查委员会（UNM称为医学和科学审查委员会）审查其科学价值。如果它们在这一级别获得批准，但缺乏支持，则将其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，MD，负责组织PSRS评价的临床研究委员会成员。如果认为不支持的方案值得支持，则将其提交给适当的IRB，如果获得批准，则由临床方案、数据管理和信息学共享资源在方案特定的财务支持下实施。PSRS研究护士是M。Pruess，数据管理员是M。阿尔雷德在2008/9财政年度，有19项由制药商发起的I-III期干预性临床试验需要UNM癌症中心的支持。这些试验在2008/2009财年共招募了222例患者。在2008/9财政年度，有11项由UNM癌症中心支持的由化疗药物启动的I期或I/II期干预性临床试验。这些试验共纳入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的后期临床试验。UNM癌症中心对早期临床试验的支持表明了一个积极的方案特定的研究支持计划。