CB: Biostatistics and Data Management Core

基于为以下项目提供生物统计支持和数据管理基础设施的良好记录 转化性研究，德克萨斯大学生物统计和数据管理核心(BDMC)。 安德森癌症中心(UTMDACC)头颈部孢子是一个综合性、多面性的资源 用于获取、管理和集成数据、设计临床和基础科学实验、执行 统计分析，构建全面风险评估模型，发展创新统计 方法，并发表从该H&N孢子产生的研究结果。在我们的第一笔资金中 周期，BDMC显著增强了M.D.Anderson头/颈组织的数据库基础设施 Bank和甲骨文临床数据库进行了两项临床试验。我们已经开发并在线发布了第一个 头颈部组织库的通用数据元素(CDE)。基于CDE的，我们建立了一个 全面的、基于网络的组织银行数据管理系统，目前存储了338,000多个 来自29,000多名患者的组织样本(新鲜、石蜡、玻片或液体样本)。组织银行 数据管理系统还提供广泛的查询和报告功能。此外，在 与NCI的工作人员合作，我们开发了两个临床试验数据管理系统，基于 Oracle Clinic，它允许远程数据捕获，是孢子间扩展的理想选择 合作。对于这次续期申请，我们将继续确保纳入声音 每个项目中的实验设计原则，将增加清晰度并增强可解释性 研究结果。将为每个项目提供量身定制的分析，并伴随着新的统计数据 根据需要进行开发，以揭示数据之间的显性和隐性关系。BDMC将 提供综合数据管理系统设计方面的专业知识，以促进沟通 在所有项目和核心中。这一过程包括前瞻性数据收集、数据质量控制、数据 安全、数据管理、数据集成和患者机密性保证。BDMC将 继续为整个HN孢子提供统计支持，包括体外/体内设计 实验、临床试验、样本量/能量计算、统计数据分析、统计准备 临床试验报告，并在相关出版物的开发方面进行合作。

Based on a strong track record of providing biostatistical support and data management infrastructure for translational research, the Biostatistics and Data Management Core (BDMC) of the University of Texas M.D. Anderson Cancer Center (UTMDACC) Head and Neck SPORE is a comprehensive, multi-lateral resource for acquiring, managing, and integrating data, designing clinical and basic science experiments, performing statistical analysis, building comprehensive risk assessment models, developing innovative statistical methodology, and publishing the research results generated from this H&N SPORE. In our first funding cycle, BDMC significantly enhanced the database infrastructure for the M. D. Anderson Head/Neck Tissue Bank and the Oracle Clinical Database for two clinical trials. We have developed and posted on-line the first common data element (CDE) for the head and neck tissue bank. Based on the CDE's, we built a comprehensive, web-based, data management system for the tissue bank that now stores over 338,000 tissue samples (fresh, paraffin, slide, or fluid samples) from more than 29,000 patients. The Tissue Bank Data Management System also provides extensive query and reporting capabilities. In addition, in collaboration with staff at NCI, we have developed two clinical trial data management systems, based on Oracle Clinical, which allows for remote data capture and is ideal for expanding for inter-SPORE collaborations. For this renewal application, we will continue to ensure the incorporation of sound experimental design principles within each project that will increase the clarity and enhance interpretability of study results. Each project will be provided with tailored analyses, accompanied by novel statistical development as necessary, to reveal apparent and hidden relationships among data. The BDMC will provide expertise in the design of an integrated data management system to facilitate communication among all projects and cores. This process includes prospective data collection, data quality control, data security, data management, data integration, and assurance of patient confidentiality. The BDMC will continue to provide statistical support for the entire HN SPORE, including design of in vitro/in vivo experiments, clinical trials, sample size/power calculations, statistical data analysis, preparation of statistical reports for clinical trials, and collaborating in the development of related publications.