CB: Biostatistics and Data Management Core

CB：生物统计学和数据管理核心

• 批准号: 7934020
• 负责人: J. Jack LEE
• 金额: $ 25.2万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7934020
• 关键词: Basic Science; Biological Markers; Biometry; Biostatistics Core; Cancer Center; Clinical; Clinical Trials; Collaborations; Collection; Common Data Element; Communication; Confidentiality of Patient Information; Data; Data Collection; Data Quality; Data Security; Database Management Systems; Databases; Development; Doctor of Medicine; Drug Interactions; Ensure; Epidemiologic Studies; Experimental Designs; Funding; Head; Head and Neck Cancer; Head and neck structure; In Vitro; Lateral; Lesion; Liquid substance; Methodology; Modeling; Molecular; Multi-Institutional Clinical Trial; National Cancer Institute; Online Systems; Oral; Paraffin; Patients; Premalignant; Preparation; Process; Publications; Publishing; Quality Control; Reporting; Reproduction spores; Research; Research Infrastructure; Research Personnel; Resources; Risk Assessment; Role; Sample Size; Sampling; Side; Slide; Statistical Data Interpretation; Statistical Methods; System; Testing; Texas; Tissue Banking; Tissue Banks; Tissue Sample; Tissues; Translational Research; Universities; base; data integration; data management; design; in vivo; indexing; innovation; malignant mouth neoplasm; novel; pre-clinical; prognostic; prospective; repository; research study; sound; tool

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.

基于为以下领域提供生物统计支持和数据管理基础设施的良好记录 转化研究，德克萨斯大学医学博士生物统计学和数据管理核心（BDMC） 安德森癌症中心 (UTMDACC) 头颈 SPORE 是一个综合性的多边资源 用于获取、管理和整合数据，设计临床和基础科学实验，执行 统计分析，建立全面的风险评估模型，开发创新统计 方法，并发布 H&N SPORE 产生的研究结果。在我们的第一笔资金中 周期中，BDMC 显着增强了 M.D. Anderson 头颈组织的数据库基础设施 Bank和Oracle临床数据库进行了两项临床试验。我们已经开发并发布了第一个 头颈组织库的通用数据元素 (CDE)。基于CDE，我们构建了一个 组织库的全面、基于网络的数据管理系统，目前存储超过 338,000 个组织库 来自超过 29,000 名患者的组织样本（新鲜、石蜡、载玻片或液体样本）。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 Clinical，允许远程数据捕获，是 SPORE 间扩展的理想选择 合作。对于本次续展申请，我们将继续确保纳入合理的内容 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。每个项目都将提供量身定制的分析，并附有新颖的统计数据 必要时进行开发，以揭示数据之间明显和隐藏的关系。 BDMC 将 提供集成数据管理系统设计方面的专业知识以促进沟通 在所有项目和核心之间。这个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、数据集成以及患者机密性保证。 BDMC 将 继续为整个HN SPORE提供统计支持，包括体外/体内的设计 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。