CORE--Clinical, Biostatistical and Data Management

核心——临床、生物统计和数据管理

• 批准号: 7796693
• 负责人: PAUL N LANKEN
• 金额: $ 35.67万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-05-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7796693
• 关键词: Acute Lung Injury; Address; Antioxidants; Biological; Biometry; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Consultations; Data; Data Analyses; Data Set; Enrollment; Gene Expression; Generations; Goals; Human Resources; Laboratories; Lead; Manuscripts; Methods; Microarray Analysis; Molecular; National Heart, Lung, and Blood Institute; Outcome; Patients; Pennsylvania; Phase; Preparation; Proteomics; Reactive Oxygen Species; Reporting; Research; Research Design; Research Personnel; Research Subjects; Resolution; Resources; Risk Factors; Role; Sample Size; Sampling; Services; Source; Statistical Data Interpretation; System; Training; Trauma; University Hospitals; Validation; Writing; abstracting; clinical epidemiology; cohort; data management; design; functional genomics; high risk; innovation; model development; prospective; quality assurance

The goal is to provide integrated resources for enrolling eligible subjects, collecting clinical data and biological samples, and providing design and data analytic services to support all PPG investigators. Moreover, we will provide comprehensive data management services. We will provide a broad range of collaborations by assisting with study design, biostatistical analyses, interpretation iof results, and manuscript preparation. In particular, co-investigators will provide specialized expertise in functional genomics, analytic methods for characterizing the relationships among high-dimensional molecular level data and clinical outcomes, analytic methods for gene expression data arising from microarray technologies, and innovative methods for analysis of the proteomics data. The Specific Aims are: 1. Clinical: (a) Continue the previous NHLBI SCOR in Acute Lung Injury (ALl SCOR) prospective cohort of major trauma patients ("Trauma Cohort") who are at high risk for developing ALl within 5 days of trauma; (b) utilize the Trauma Cohort to provide eligible subjects and biological samples; (c) continue the previous ALl SCOR's system to collect clinical data and biological samples from patients enrolled in Trauma Cohort. 2. Biostatistical: (a) Advise investigators on study design issues, including sample size and power considerations; (b) conduct statistical analyses of data from laboratory projects and risk factor model development for clinical investigations to address specific research hypotheses defined in the project-specific proposals; (c) assist with preparation for and writing of interim and final reports, presentations, abstracts, and manuscripts; (d) conduct exploratory analyses that may lead to generation of new hypotheses. 3. Data Management: (a) Modify and implement the Data Management System (DMS) for the Trauma Cohort; (b) provide training and assistance for research staff; (c) conduct all phases of quality assurance, validation, query resolution and reporting for clinical studies; (d) create valid datasets of high scientific quality, combining data from multiple sources for biostatistical analyses.

目标是为登记符合条件的受试者提供综合资源，收集临床数据 和生物样本，并提供设计和数据分析服务，支持所有PPG调查人员。此外，我们还将提供全面的数据管理服务。我们会 通过协助研究设计、生物统计分析、结果解释和手稿准备，提供广泛的合作。特别是，合作研究人员将提供功能基因组学方面的专门知识，描述高维分子水平数据与临床结果之间关系的分析方法，来自微阵列技术的基因表达数据的分析方法，以及蛋白质组学数据分析的创新方法。具体目标是：1.临床：(A)在急性肺损伤(ALL SCOR)中继续以前的NHLBI SCOR：在创伤后5天内有高风险发生ALL的重大创伤患者的预期队列(“创伤队列”)；(B) 利用创伤队列提供符合条件的受试者和生物样本；(C)继续以前的ALL SCOR系统，从患者那里收集临床数据和生物样本 参加了创伤队列。2.生物统计学：(A)就研究设计问题向研究人员提供咨询，包括样本量和能力考虑；(B)对实验室项目的数据进行统计分析，并为临床调查开发风险因素模型，以处理项目具体提案中确定的具体研究假设；(C)协助编写中期和最终报告、陈述、摘要和 手稿；(D)进行探索性分析，可能导致产生新的假设。 3.数据管理：(A)修改和实施创伤队列的数据管理系统；(B)为研究人员提供培训和援助；(C)开展所有阶段的 为临床研究提供质量保证、验证、查询解决和报告；(D)创建高科学质量的有效数据集，将来自多个来源的数据结合起来进行生物统计分析。