BIOSTATISTICS SHARED RESOURCE

生物统计学共享资源的总体目标是建立和保持尽可能高的 由NCCC计划进行的癌症研究的统计和科学质量标准。的 资源为所有NCCC成员提供专家统计咨询和分析;研究设计，统计 临床试验方案的审查和中期监测;大型临床试验的统计设计和专家协作 大规模癌症控制和流行病学研究; 综合生物学和实验室研究;统计数据管理专门知识;和 统计软件支助和硬件使用。该资源由七名教师统计学家组成， 三名统计/数据管理/程序员分析员。教师统计专业知识和研究领域 包括纵向数据分析和研究设计，临床研究中测量误差方法， 流行病学，临床试验和流行病学研究的统计方法，高 三维基因组和成像数据，临床决策建模，成本效益分析，以及 诊断测试评估。 BSR教师为NCCC临床癌症研究和安全与数据提供统计专业知识 批准和监测临床方案的监测委员会。BSR主任担任 他是癌症研究委员会的成员，每周与NCCC的其他核心领导人会面。所述BSR 教师是整个NCCC众多NCI资助项目的积极合作者， 参加所有定期计划的会议。信息技术和数据管理 NCCC的活动与BSR、NCCC管理局、临床医学办公室 研究和生物信息学共享资源。BSR数据管理专家担任 NCCC临床信息系统总监，并为正在进行的 开发临床研究数据系统。 计划在这一赠款期间采取的新举措包括进一步发展统计教育 为NCCC内各级研究人员举办研讨会和讲习班， 基于新的临床信息系统进行报告，以提供实时的临床试验安全性和数据 监测和获取研究数据。

The overarching goal of the Biostatistics Shared Resource is to establish and maintain the highest possible standards of statistical and scientific quality in the cancer research conducted by the NCCC Programs. The resource provides expert statistical consultation and analysis for all NCCC members; study design, statistical review and interim monitoring for clinical trial protocols; statistical design and expert collaboration for large scale cancer control and epidemiology studies; experimental design and specialized statistical methods for integrative biology and laboratory-based research; statistical data management expertise; and specialized statistical software support and hardware access. The resource is staffed by seven faculty statisticians and three statistical/data management/programmer analysts. Areas of faculty statistical expertise and research include longitudinal data analysis and study design, measurement error methods in clinical research and epidemiology, statistical methods for clinical trials and epidemiology studies, statistical methods for high dimensional genomic and imaging data, clinical decision modeling, cost-effectiveness analysis, and diagnostic test assessment. The BSR faculty provides statistical expertise to the NCCC Clinical Cancer Research and Safety and Data Monitoring Committees for approving and monitoring clinical protocols. The Director of the BSR serves as a member of the Cancer Research Committee and meets weekly with the other NCCC core leaders. The BSR faculty members are active collaborators on numerous NCI-funded projects throughout NCCC and participate in all regularly scheduled Program meetings. Information technology and data management activities at NCCC are managed in coordination with the BSR, NCCC Administration, the Office of Clinical Research, and the Bioinformatics Shared Resource. The BSR data management specialist serves as the NCCC Director of Clinical Information Systems, and provides technical leadership for the ongoing development of clinical research data systems. New initiatives planned for this grant period include the further development of statistical educational seminars and workshops, for researchers at all levels within NCCC, and development of interactive statistical reporting based on the new clinical information system to provide real-time clinical trial safety and data monitoring and access to research data.