CB: Biostatistics and Data Management Core

基于为提供生物统计支持和数据管理基础设施的良好记录 翻译研究，生物统计学和数据管理核心（BDMC）的德克萨斯大学医学博士。 安德森癌症中心（UTMDACC）头颈部孢子是一个全面的，多边的资源 用于获取、管理和整合数据，设计临床和基础科学实验， 统计分析，建立全面的风险评估模型，开发创新的统计 方法，并发表从这个H&N SPORE产生的研究结果。在我们的第一笔资金中 循环，BDMC大大增强了数据库基础设施的M。D.安德森头部/颈部组织 Bank和Oracle临床数据库，用于两项临床试验。我们开发并发布了第一个 用于头颈部组织库的通用数据元素（CDE）。基于CDE，我们建立了一个 一个全面的、基于网络的组织库数据管理系统，目前存储了超过338，000个 来自29，000多名患者的组织样本（新鲜、石蜡、载玻片或液体样本）。组织库 数据管理系统还提供了广泛的查询和报告功能。另外在 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， Oracle Clinical，允许远程数据捕获，非常适合扩展到跨SPORE 合作。对于此更新应用程序，我们将继续确保纳入健全的 每个项目中的实验设计原则，将增加清晰度和增强可解释性 的研究结果。每个项目都将提供量身定制的分析，并附有新的统计数据。 必要时进行开发，以揭示数据之间明显和隐藏的关系。BDMC将 提供设计综合数据管理系统的专门知识，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 安全性、数据管理、数据集成和保证患者机密性。BDMC将 继续为整个HN SPORE提供统计支持，包括体外/体内设计 实验、临床试验、样本量/功效计算、统计数据分析、统计准备 临床试验报告，并合作开发相关出版物。

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.