Biostatistics, Informatics, and Data Coordination

生物统计学、信息学和数据协调

• 批准号: 8805233
• 负责人: JAMES E HERNDON
• 金额: $ 22.56万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-24 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8805233
• 关键词: Address; Biometry; Brain; Brain Neoplasms; Case Report Form; Clinical; Clinical Data; Clinical Investigator; Clinical Research; Collaborations; Collection; Computers; Confidentiality of Patient Information; Data; Data Analyses; Data Collection; Data Coordinating Center; Data Quality; Data Set; Databases; Development; Dictionary; Elements; Ensure; Family; Future; Goals; Health Services; Health system; Informatics; Institutes; Institution; Laboratories; Leadership; Link; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of brain; Manuscripts; Methods; Mind; Modeling; Monitor; Outcome; Patient Outcomes Assessments; Patients; Preparation; Primary Brain Neoplasms; Procedures; Process; Quality Control; Randomized; Records; Reporting; Reproducibility; Research; Research Design; Research Infrastructure; Research Personnel; Resource Sharing; Resources; Sample Size; Scientist; Secure; Security; Services; Software Tools; Solutions; Specimen; Staging; Standardization; Statistical Data Interpretation; System; Technical Expertise; Technology; Test Result; Tissues; Translational Research; Trust; Universities; anticancer research; career development; data acquisition; data format; data integrity; data management; data sharing; data structure; design; electronic data; meetings; member; pre-clinical; programs; quality assurance; software development; tool

The overarching purpose of the Biostatistics, Informatics, and Data Coordination Core is to provide expert data analysis and data management to support all studies in the SPORE in Brain Cancer. Core B will ensure not only the timeliness and efficiency, but also the scientific integrity and quality, of the proposed SPORE studies by providing an infrastructure that offers, across studies: (1) expertise and technical support; (2) sophisticated but streamlined analytic, informatics, and data-related methods; (3) tools and procedures to help investigators exploit cutting-edge data and informatics capabilities while employing consistent, high-quality, research practices; and (4) a central access point that coordinates available resources such as institutional datasets. Staffed by biostatistics and informatics experts, database architects, computer scientists, and data managers, this Core builds upon and fortifies successful and longstanding collaborations with Brain SPORE and Duke Cancer Institute (DCI) investigators and our commitment to data standards and quality control. Core B leverages the Preston Robert Tisch Brain Tumor Center, DCI, and Duke University Health System shared resources, to provide SPORE investigators with centralized biostatistical expertise, state-of-the-art technology and database solutions, and access to an enduring coordinated data resource, tailored to meet the needs of brain cancer research. Specific aims addressed by this Core include: (1) To provide biostatistical leadership and expertise in the design, conduct, analysis, and reporting of Brain SPORE studies. Biostatistical collaboration will span all project stages: study design, sample size calculations, randomization, monitoring, analysis and interpretation, and manuscript preparation. (2) To be the SPORE data coordination center by providing services in data acquisition, transfer, integration, quality control, management and sharing for the SPORE in Brain Cancer Projects and Cores. In order to achieve this aim, Core B will ensure that there is a coordinated system for data collection, storage, and standardization; quality assurance and monitoring of data quality; access to tools and software; and promotion of data management best practices throughout the SPORE, including a system of common data management standardized operating procedures (SOPs) and agreed data governance, in order to ensure data integrity, provenance and security and reproducibility study findings. Finally, (3) To develop a longitudinal brain tumor outcomes database (“datamart”) that will serve as an enduring resource for brain cancer research at Duke. Leveraging institutional resources, this datamart will integrate information from Brain SPORE databases and institutional databases including clinical, health services and patient-reported outcomes to create a large clinical and research dataset for current and future analyses.

生物统计学、信息学和数据协调核心的首要目的是提供专家数据 支持 SPORE 脑癌核心 B 中所有研究的分析和数据管理将确保不会出现这种情况。 所提议的 SPORE 研究不仅包括及时性和效率，还包括科学完整性和质量 通过提供跨研究的基础设施：(1) 专业知识和技术支持；(2) 先进的技术支持； 但简化了分析、信息学和数据相关方法；(3) 帮助调查人员的工具和程序； 利用尖端的数据和信息学能力，同时采用一致的、高质量的研究 实践；(4) 协调可用资源（例如机构数据集）的中央访问点。 由生物统计学和信息学专家、数据库架构师、计算机科学家和数据经理组成， 该核心建立在与 Brain SPORE 和 Duke 的成功和长期合作的基础上并加强了合作 癌症研究所 (DCI) 的研究人员以及我们对数据标准和质量控制核心 B 的承诺。 利用 Preston Robert Tisch 脑肿瘤中心、DCI 和杜克大学医疗系统共享 资源，为 SPORE 研究人员提供集中的生物统计专业知识和最先进的技术 和数据库解决方案，以及访问持久的协调数据资源，专为满足以下需求而量身定制 该核心解决的具体目标包括：(1) 提供生物统计领导力。 以及脑孢子生物统计研究的设计、实施、分析和报告方面的专业知识。 合作将跨越所有项目阶段：研究设计、样本量计算、随机化、监测、 (2) 成为SPORE数据协调中心 为企业提供数据采集、传输、集成、质量控制、管理和共享等服务 脑癌项目和核心中的 SPORE 为了实现这一目标，核心 B 将确保有一个 数据收集、存储和标准化的协调系统； 质量；工具和软件的获取；以及在整个过程中推广数据管理最佳实践。 SPORE，包括通用数据管理标准化操作程序 (SOP) 系统和 商定的数据治理，以确保数据完整性、来源、安全性和可重复性研究 最后，(3) 开发一个纵向脑肿瘤结果数据库（“数据集市”），作为一个数据库。 该数据集市利用杜克大学脑癌研究的持久资源。 整合来自 Brain SPORE 数据库和机构数据库（包括临床、健康）的信息 服务和患者报告的结果，为当前和未来创建大型临床和研究数据集 分析。