Protocol Specific Research

项目总结（见说明）： 方案特定研究支持（PSRS） 创新的临床研究，特别是与UMCCC基础研究相关的研究，以及涉及试验性或I期前或I期临床试验的研究，这些试验测试了候选药物或器械用于诊断、预防、检测或治疗癌症的临床干预措施，可能符合方案特定研究支持（PSRS）的条件。这种支持将用于研究协调员的活动和数据管理 功能协调发展的这些研究方案的数据可用于支持这些干预措施的后期活动，或作为从其他来源获得资金以继续试点活动的基础。PSRS提供的这种关键的早期支持对于推进此类试验是必要的，特别是因为每位患者的费用不报销。PSRS，利用最近修订的（2008年）国家癌症研究所指南 研究所（NCI）将支持UMCCC的研究协调员和数据管理员，以促进这些创新的临床研究工作。只有在符合临床研究委员会判定的其他标准后，PSRS支持的试验才会获得此类资金的批准。这些试验将根据方案在促进新型癌症诊断、治疗、成像或预防策略的发展方面的重要性和创新性而被分配优先级。其他标准包括证据表明，拟议的试验具有相关的科学，这些科学将由于PSRS资助而得到关键性的支持，翻译合作者和检测方法已经到位，并且PSRS资助的使用将允许为研究策略开发独立或未来的资助工具。在UMCCC的投资组合中，最近（2009年）批准的22项药物启动的试验中有5项可能有资格获得长达1年的研究护士和数据管理员支持，这与新的PSRS指南（限制使用类型和适用的PSRS资助期限）雅阁。这种支持将使UMCCC能够灵活地推进高优先级，创新，早期临床试验的事业。这些试验将没有或充其量只有部分行业支持，不包括每名患者的成本。理想情况下，PSRS支持的研究将来自研究者发起的临床研究，或者是基础科学家之间联盟的逻辑结果， UMCCC和临床医生谁是适合解决转化科学的目标，不纳入NCI或其他资助机构的其他资助支持的试验。

PROJECT SUMMARY (See instructions): Protocol-Specific Research Support (PSRS) Innovative clinical research, especially that tied to UMGCC basic research and involving pilot or pre Phase I, or Phase I investigator-initiated trials testing clinical interventions with a candidate agent or device for the diagnosis, prevention, detection, or treatment of cancer may be eligible for Protocol Specific Research Support (PSRS). Such support will underwrite research coordinator activities and data management functions. Data from such research protocols can be used to support later phase activities with these interventions, or as a basis for acquiring funding from other sources to continue the piloted activities. This critical early support provided by PSRS, is necessary to move such trials forward, especially because per patient costs are not reimbursed. PSRS, utilizing recently revised (2008) guidelines from the National Cancer Institute (NCI) for its use, will support research coordinators and data managers at UMGCC to facilitate these innovative clinical investigation efforts. Trials supported by PSRS will be approved for such funding only after meeting additional criteria as judged by the Clinical Research Committee. The trials will be assigned a priority scale for funding based on how the protocol is, respectively, significant and innovative in promoting the development of a novel cancer diagnosis, treatment, imaging, or prevention strategy. Additional criteria include evidence that the proposed trial possesses correlative science that will be critically enabled as a result of PSRS funding, with translational collaborators and assays in place, and the use of PSRS funding will allow the development of independent or future funding vehicles for the research strategy. Five of 22 recently (CY2009) approved investigator-initiated trials in UMGCC's portfolio potentially qualify for the up to 1 year of research nurse and data manager support in accord with the new PSRS guidelines limiting the type of use and period of applicable PSRS funding. This support will give UMGCC the flexibility to advance the cause of high-priority, innovative, early phase clinical trials. These trials will have no or at best partial industry support, excluding per-patient costs. Ideally, PSRS-supported studies would flow from investigator initiated clinical research, or would be the logical consequence of an alliance between basic scientists at UMGCC and clinicians who are suitable for addressing a translational science goal that is not incorporated into other grant-supported trials of NCI or other funding agencies.