University of Michigan Comprehensive Cancer Center CCOP*

描述(由申请者提供)：密歇根大学综合癌症中心(UMCC)是一个由NCO核心赠款支持的矩阵组织的综合癌症中心，该中心建议更新一个仅专注于癌症预防和控制的CCOP研究基地。在过去的五年中，研究基地建立了开发、审查、激活、管理数据和监测临床研究的基础设施。它已经与8个CCOP建立了密切的合作关系，其中包括3个基于少数族裔的CCOP，正在努力与另外两个CCOP建立联系，启动了3个翻译、外部同行审查和资助的癌症预防和控制方案，还有一个正在NCI CCOP审查系统中等待批准。在开发基于网络的登记和样品跟踪系统方面取得了进展。本提案的具体目的是：1.描述密歇根大学癌症中心研究基地组织2.描述CCOP如何整合到研究基地组织中。3.概述癌症预防控制研究发展和实施的组织过程。4.描述研究基地未来3年的癌症预防和控制研究。5.描述质量控制和监测以及6.展示密歇根大学癌症中心CCOP研究基地如何支持并将继续支持服务不足的少数族裔参加转化型癌症预防研究。 为了满足这些具体目标，UMCCC CCOP研究基地建立了技术支持，以处理符合当前良好临床实践和NCI指南的数据。其中包括内部数据质量控制方法、审计程序、数据管理方法、ADR报告程序、对人类受试者的保护以及CCOP的业绩指南。CCOP的治理由一个CCOP研究基地执行委员会和一个数据安全和监测委员会组成。所有的概念和方案必须得到研究基地PI或COIS和研究基地生物统计学家、UMCCC议定书审查委员会的批准。研究的重点是第一阶段和第二阶段的化学预防方案、生物标记物的发现和验证项目，以及控制和预防癌症的补充和替代医学方法。协议的结构是为了提供必要的初步数据，以值得考虑需要国家合作小组资源的更大规模的试验。与基于少数群体的社区合作伙伴建立了联系，以加强对服务不足的少数群体的招募。

DESCRIPTION (provided by applicant): The University of Michigan Comprehensive Cancer Center (UMCC), a matrix organized, NCO Core Grant supported Comprehensive Cancer Center, proposes a renewal of a CCOP Research Base focused solely on Cancer Prevention and Control. Over the last five years, the Research Base has established an infrastructure to develop, review, activate, manage data, and monitor clinical research. It has developed close collaborative relationships with eight CCOPs including three minority based CCOPs, is working on affiliation with two more CCOPs, activated three translational, extramurally peer reviewed and funded Cancer Prevention and Control Protocols and has one awaiting approval in the NCI CCOP review system. Progress in the development of a Web-based registration and sample tracking system has been made. The specific aims of this proposal are to: 1. To describe University of Michigan Cancer Center Research Base Organization 2. To describe how CCOPs are integrated into the Research Base Organization. 3. To outline the organization process for development and implementation of cancer prevention and control research. 4. To describe Cancer Prevention and Control Research for the next 3 years in the Research Base. 5. To describe Quality Control and Monitoring and 6. To demonstrate how the University of Michigan Cancer Center CCOP Research Base has supported and will continue to support enrollment of underserved minorities in translational Cancer Prevention Research. To meet these specific aims, the UMCCC CCOP Research Base has established the technical support to handle data meeting current Good Clinical Practice and NCI guidelines. These include internal data quality control methods, auditing procedures, data management methods, ADR reporting procedures, protections of human subjects, and performance guidelines for CCOPs. Governance of the CCOP consists of a CCOP Research Base Executive Committee, and a Data Safety and Monitoring Board. All concepts and protocols must be approved by Research Base PI or CoIs and Research Base biostatistician, the UMCCC Protocol Review Committee. Research focuses upon Phase I and II chemoprevention protocols, biomarker discovery and validation projects, and complementary and alternative medicine approaches to control and prevent cancer. Protocols are structured to provide the necessary preliminary data to merit consideration for larger trials requiring the resources of National Cooperative Groups. Affiliations with Minority Based CCOPs have been forged to enhance recruitment of underserved minorities.