CORE--BIOSTATISTICS AND DATA MANAGEMENT

核心——生物统计和数据管理

• 批准号: 6237621
• 负责人: CAREY E FLOYD
• 金额: $ 19.72万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-01 至 1998-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6237621
• 关键词: biomedical facility; breast neoplasms; human data; statistics /biometry

The Biostatistics and Computing Core for the Duke SPORE in Breast Cancer is intended to expedite planning and conduct of translational research. This Core will be developed in combination with the Institute of Statistics and Decision Sciences and the Duke Tumor Registry. The Biostatistics and Computing Core will not duplicate existing resources but will enhance Tumor Registry resources for the purposes of this SPORE. Dr. Donald Berry, Professor of the Institute of Statistics and Decision Sciences and statistician for the Cancer and leukemia Group B (CALGB) Breast Cancer Committee, and Dr. Carey Floyd, Associate Professor of Radiology and Biomedical Engineering and is Co-Director of the Duke Tumor Registry, will be managers of this Core. The remaining staff for this Core will include one additional statistician, Constance Cirrincione, who is the staff statistician on the CALGB Breast Cancer Committee. This Core will provide assistance in the statistical aspects of design, conduct, and analysis of basic and clinical scientific studies. Projects involving clinical research will make use of this Core to facilitate efficient clinical trial conduct, proper quality assurance, and timely evaluation and reporting of data. A computerized database using INGRES software will be run on a VAX 4500 with linkage to VT100 terminals or personal computers outfitted with Kermit or Procomm software. A generic set of breast cancer forms has been created, with monthly entry of data into the computerized data base. In addition, individual data entry screens will be developed for specific projects. The data system has automated error checking features, and incorporates standard data security features. Reports on demographics, toxicity, dose intensity, and response can be generated. Data can be transferred into the SAS/stat database for statistical analysis. This Core will also coordinate quality control efforts for the SPORE clinical trials. Monthly clinical trial reports will be circulated to investigators, and will be reviewed at the monthly Core meetings. Six- month summaries of these reports will be reviewed at the biannual review sessions. Annual audits of ongoing clinical trials will be performed by a team consisting of the Core statistician, Dr. Berry, the Principal Investigator of the SPORE, Dr. Iglehart, and one member of the Advisory Board. In addition, this Core will be a resource for the quantitative but non-clinical-trial aspects of the SPORE. This includes aiding in the use of models for assessing the level of genetic susceptibility in Project 3 and assessing the utility of surrogate markers for chemoprevention in Project l.

乳腺癌中杜克孢子的生物统计学和计算核心 旨在加快转化研究的计划和进行。 该核心将与研究所结合开发 统计和决策科学和杜克肿瘤注册表。这 生物统计学和计算核心不会复制现有资源，而是 将出于该孢子的目的增强肿瘤注册资源。博士 统计与决策研究所教授唐纳德·贝里（Donald Berry） 癌症和白血病B（CALGB）的科学和统计学家 乳腺癌委员会和副教授Carey Floyd博士 放射学和生物医学工程，是杜克肿瘤的联合导演 注册表将是该核心的经理。该核心的其余人员 将包括另外一位统计学家，康斯坦斯·塞里林辛（Constance cirrincione） Calgb乳腺癌委员会的统计学家。这个核心 将在设计，行为和 基础和临床科学研究的分析。涉及的项目 临床研究将利用该核心来促进高效 临床试验，适当的质量保证和及时评估 和数据报告。使用Ingres软件的计算机数据库将 在VAX 4500上运行，并与VT100终端或个人计算机链接 配备了Kermit或Procomm软件。一套通用的乳腺癌 已经创建了表格，每月将数据输入计算机化 数据库。此外，将开发单个数据输入屏幕 用于特定项目。数据系统具有自动错误检查 功能，并包含标准数据安全功能。报告 可以产生人口统计学，毒性，剂量强度和反应。 数据可以转移到SAS/STAT数据库中以进行统计 分析。该核心还将协调质量控制工作 孢子临床试验。每月临床试验报告将被分发 向调查人员进行调查，并将在每月的核心会议上进行审查。六- 这些报告的月份摘要将在双年度评论中进行审查 会议。对正在进行的临床试验的年度审核将由 由核心统计学家，校长贝里博士组成的团队 孢子的调查员伊格哈特博士和咨询的一名成员 木板。此外，该核心将是定量的资源，但 孢子的非临床试验方面。这包括帮助使用 评估项目3中遗传敏感性水平的模型 并评估替代标志物在化学预防中的效用 项目l。