BIOSTATISTICS AND DATA MANAGEMENT CORE

生物统计和数据管理核心

• 批准号: 6990042
• 负责人: J. Jack LEE
• 金额: $ 16.14万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-01 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6990042
• 关键词: biomedical facility; data collection; data management; experimental designs; international cooperation; method development; mouth neoplasms; statistics /biometry

DESCRIPTION (provided by applicant): The Biostatistics and Data Management Core for the University of Texas M. D. Anderson Cancer Center Oral Cancer P01 will be a comprehensive, multi-lateral resource for data acquisition and management, designing clinical and basic science experiments, developing innovative statistical methodology, statistical analysis, and publishing translational research generated by the program project. The Biostatistics and Data Management Core will incorporate 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 Biostatistics and Data Management Core 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, and assurance of patient confidentiality. The Biostatistics and Data Management Core will collaborate with all project investigators to facilitate the timely publication of all data collected under the P01 research program. The main objectives of the Biostatistics and Data Management Core are: 1. To provide the statistical design, sample size and power calculations for each project. 2. To facilitate prospective collection, entry, quality control, and integration of data for the basic science, pre-clinical, clinical, and epidemiological studies associated with the Oral Cancer P01. 3. To provide study monitoring and conduct that ensures patient safety by timely reporting of toxicity and interim analysis results to various IRBs, the Data Monitoring Committee, the NCI, and other regulatory agencies. 4. To develop a secure, international, internet-driven database network between the Norwegian Radium Hospital and UTMDACC that integrates the clinical data generated by the clinical research program and subsequent epidemiological and basic science research efforts of the program project. 5. To develop a comprehensive web-based database management system for tracking, distribution, and central repository of all Oral Cancer P01 biomarker data. 6. To provide all statistical data analysis including descriptive statistical analysis, hypothesis testing, estimation, and modeling of prospectively generated data. 7. To develop & adapt innovative statistical methods pertinent to biomarker-integrated translational oral cancer studies. 8. To generate statistical reports for all projects and to collaborate and assist all project investigators in the publication of scientific results.

描述（由申请人提供）： 德克萨斯大学M. D.安德森癌症中心口腔癌P01将是一个全面的，多方面的资源，数据采集和管理，设计临床和基础科学 实验，开发创新的统计方法，统计分析和出版 项目产生的转化研究。生物统计学和数据管理核心将在每个项目中纳入合理的实验设计原则，这将提高研究结果的清晰度和可解释性。将为每个项目提供有针对性的分析，并在必要时提供新的统计发展，以揭示数据之间明显和隐藏的关系。生物统计和数据管理核心将提供设计综合数据管理系统的专门知识，以促进所有项目和核心之间的沟通。该过程包括前瞻性数据收集、数据质量控制、数据安全性和患者保密性保证。生物统计学和数据管理核心将与所有项目研究者合作，以促进及时发布根据P01研究计划收集的所有数据。生物统计和数据管理核心的主要目标是： 1.提供每个项目的统计设计、样本量和功效计算。 2.促进与口腔癌P01相关的基础科学、临床前、临床和流行病学研究的前瞻性收集、录入、质量控制和数据整合。 3. 通过及时向各IRB、数据监查委员会、NCI和其他监管机构报告毒性和中期分析结果，提供研究监查和实施，确保患者安全。 4.在挪威镭医院和UTMDACC之间开发一个安全的、国际化的、互联网驱动的数据库网络，该网络集成了临床研究项目生成的临床数据以及该项目项目后续的流行病学和基础科学研究工作。 5.开发一个全面的基于网络的数据库管理系统，用于跟踪、分发和集中储存所有口腔癌P01生物标志物数据。 6.提供所有统计数据分析，包括描述性统计分析、假设检验、估计和前瞻性生成数据的建模。 7.开发和调整与生物标志物整合的转化性口腔癌研究相关的创新统计方法。 8.为所有项目生成统计报告，并协助所有项目研究人员发表科学成果。