Core C - Biostatistics and Data Mangement Core

核心 C - 生物统计和数据管理核心

• 批准号: 10006196
• 负责人: Wei-Ting Hwang
• 金额: $ 11.92万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-14 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10006196
• 关键词: Address; Adherence; Antigens; Basic Science; Bioinformatics; Biomedical Research; Biometry; Biostatistics Core; Case Report Form; Clinical; Clinical Trials; Clinical Trials Database; Collaborations; Complex; Consult; Data; Data Analyses; Data Management Resources; Goals; Graph; Health; Institutes; Knowledge; Malignant Neoplasms; Malignant neoplasm of lung; Malignant neoplasm of thorax; Manuscripts; Methodology; Methods; Monitor; Monitoring Clinical Trials; Population; Preparation; Procedures; Productivity; Quality Control; Reporting; Research; Research Design; Research Personnel; Research Project Grants; Safety; Sample Size; Services; Source; Statistical Data Interpretation; T cell therapy; Translational Research; Work; anticancer research; biomedical informatics; cancer immunotherapy; data management; data quality; data sharing; design; experience; improved; mange; member; programs; recruit; research study

Core C (Biostatistics, Bioinformatics, and Data Management) Abstract Core C (Biostatistics, Bioinformatics, and Data Management) provides expert guidance and collaboration in the biostatistical, bioinformatics, and data management aspects of the design, conduct and analysis of translational research projects generated by this P01 proposal. In order to achieve these goals, the specific aims of Core C include: 1) to consult with project investigators to select efficient study designs and sample sizes that are adequate to address study objectives, 2) to work with investigators to prepare tables and graphs, to execute efficient and robust statistical and bioinformatics analyses, to draft statistical sections of project manuscripts, and to propose and implement best design and analysis strategies for subsequent studies, and 3) to provide statistical support in data management for clinical trials, projects, and cores, and promote data sharing. Specifically, prior to the initiation of studies, Core staff members will consult with project investigators to help select designs that are efficient and adequately powered. For the proposed clinical trials, Core C will collaborate to utilize existing data management systems or establish new ones if required, and design case report forms (CRF) that collect all required information in an unambiguous way. As studies proceed, staff members review data periodically to evaluate adherence to study procedures, data quality, and adequacy of underlying statistical assumptions. When studies are finished, staff members review the data again, produce informative summary tables and graphical displays, conduct correct and efficient statistical and bioinformatics analyses, and consult on the design of subsequent studies. The work of Core C involves close integration with the efforts of all the research projects. Core C staff members have extensive experience supporting cancer research, with strong backgrounds in basic science, translational research, clinical trials, bioinformatics, research computing, and data management. With their many years of experience in biomedical research, they stand ready to identify and apply ideal methods for the design and analysis, and data management of the proposed research studies. Core C offers its services to all projects and cores in this P01 proposal.

核心C（生物统计学，生物信息学和数据管理） 摘要 核心C（生物统计学，生物信息学和数据管理）提供专家指导和合作， 生物统计学、生物信息学和数据管理方面的设计、实施和分析 P01提案产生的转化研究项目。为了实现这些目标， 核心C的目标包括：1）与项目调查人员协商，以选择有效的研究设计和样本 足以解决研究目标的尺寸，2）与研究者合作准备表格和图表， 执行有效和可靠的统计和生物信息学分析，起草项目统计部分 手稿，并为后续研究提出和实施最佳设计和分析策略，以及3） 为临床试验、项目和核心的数据管理提供统计支持，促进数据 共享具体而言，在研究开始之前，核心工作人员将与项目研究者进行磋商 以帮助选择高效且功率充足的设计。对于拟定的临床试验，核心C将 合作利用现有的数据管理系统或建立新的，如果需要的话，并设计案例 报告表格（CRF），以明确的方式收集所有必需的信息。随着研究的进行，工作人员 成员定期审查数据，以评估对研究程序的依从性、数据质量和 基本的统计假设。研究结束后，工作人员再次审查数据， 信息丰富的汇总表和图形显示，进行正确和有效的统计和生物信息学 分析，并就后续研究的设计提供咨询。核心C的工作涉及与 所有研究项目的努力。核心C工作人员具有支持癌症的丰富经验 研究，在基础科学，转化研究，临床试验，生物信息学， 研究计算和数据管理。凭借多年的生物医学研究经验， 随时准备确定并应用设计和分析以及数据管理的理想方法 建议进行研究。核心C为本P01提案中的所有项目和核心提供服务。