University of Michigan Comprehensive Cancer Center CCOP*

密歇根大学综合癌症中心 CCOP*

• 批准号: 7089070
• 负责人: Dean E. Brenner
• 金额: $ 46.05万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7089070
• 关键词: Internet; behavior therapy; behavioral /social science research tag; cancer prevention; cancer risk; chemoprevention; clinical research; clinical trial phase I; clinical trial phase II; community health services; cooperative study; data management; health services research tag; human subject; medical outreach /case finding; neoplasm /cancer education; neoplasm /cancer epidemiology; oncology nursing; patient oriented research; primary care physician

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.

描述（由申请人提供）：密歇根大学综合癌症中心（UMCC），一个矩阵组织，NCO核心补助金支持的综合癌症中心，提出了一个CCOP研究基地的更新，专注于癌症预防和控制。在过去的五年里，研究基地建立了一个基础设施，以开发，审查，激活，管理数据和监测临床研究。它与八个社区合作方案建立了密切的合作关系，其中包括三个基于少数民族的社区合作方案，正在努力与另外两个社区合作方案建立联系，启动了三个翻译的、经壁外同行审查和资助的癌症预防和控制议定书，还有一个正在国家癌症研究所社区合作方案审查系统中等待批准。在开发网上登记和样本跟踪系统方面取得了进展。这项建议的具体目标是：1.描述密歇根大学癌症中心研究基地组织2。描述CCOPs如何被整合到研究基地组织中。3.概述癌症预防和控制研究的发展和实施的组织过程。4.描述研究基地未来3年的癌症预防与控制研究。5.描述质量控制和监测; 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民族在转化癌症预防研究中的入学。 为了实现这些具体目标，UMCCC CCOP研究基地已经建立了技术支持，以处理符合当前药物临床试验质量管理规范和NCI指南的数据。其中包括内部数据质量控制方法、稽查程序、数据管理方法、ADR报告程序、人类受试者保护和CCOP性能指南。CCOP的治理由CCOP研究基地执行委员会和数据安全和监测委员会组成。所有概念和方案必须得到研究基地PI或CoI和研究基地生物统计学家、UMCCC方案审查委员会的批准。研究重点是I期和II期化学预防方案，生物标志物发现和验证项目，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，以便在需要国家合作组资源的大型试验中得到考虑。与基于少数群体的社区警察方案建立了联系，以加强对服务不足的少数群体的征聘。