Biostatistics Core

生物统计学核心

• 批准号: 8588498
• 负责人: DIANNE M FINKELSTEIN
• 金额: $ 13.25万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-19 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8588498
• 关键词: Animals; Biological Markers; Biostatistics Core; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Code; Collaborations; Computing Methodologies; Confidentiality; Consult; Consultations; Core Facility; Data; Data Analyses; Data Collection; Data Set; Databases; Development; Ensure; Event; Experimental Designs; Funding; Futility; Glioma; Health; Human; Investigation; Laboratories; Laboratory Study; Manuscripts; Measurement; Medical; Methodology; Methods; Monitor; Patient Care; Patients; Preparation; Process; Research; Research Personnel; Research Support; Resources; Role; Safety; Security; Statistical Methods; Statistical Models; Time; Tissues; Translating; Translations; Variant; anticancer research; cost; data management; database design; design; high standard; molecular imaging; novel; pre-clinical; preclinical study; programs; research study

The Biostatistics Core will provide statistical support for the research conducted in the Glioma SPORE program, including related database and computing requirements. The Core will provide consultation and expertise on the development and implementation of plans for data collection, particularly the coding convention and variable format required for statistical analysis. The Core will contribute to the data management plan, including form design and database requirements, during development ofthe SPORErelated clinical trials. The Core will provide expertise and resources for data transfer, merging, sharing and security while maintaining the confidentiality of all patient-related protected health information. The Core will provide ready and dedicated access to statistical expertise for the design, planning and conduct of preclinical experiments, clinical trials and correlative tissue and biomarker studies. Analysis ofthe clinical trials will include interim monitoring, if necessary, including the stopping rules for safety and futility. The Core will also provide statistical expertise for data analysis and interpretation of research studies, including manuscript preparation.

生物统计学核心将为神经胶质瘤 SPORE 中进行的研究提供统计支持 程序，包括相关的数据库和计算要求。核心将提供咨询和 制定和实施数据收集计划的专业知识，特别是编码 统计分析所需的约定和变量格式。核心将贡献数据 SPORE相关开发过程中的管理计划，包括表单设计和数据库要求 临床试验。核心将为数据传输、合并、共享和提供专业知识和资源 安全性，同时维护所有与患者相关的受保护健康信息的机密性。核心将 为临床前的设计、规划和实施提供现成且专门的统计专业知识 实验、临床试验以及相关组织和生物标志物研究。临床试验分析将 如有必要，包括临时监控，包括安全和无效的停止规则。核心还将 提供数据分析和研究解释（包括手稿）的统计专业知识 准备。