Patient Enrollment and Data Analysis

患者登记和数据分析

• 批准号: 8464249
• 负责人: Andrew S Weyrich
• 金额: $ 31.89万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-05-01 至 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8464249
• 关键词: Age; Bioinformatics; Blood; Blood Clot; Blood Platelets; Blood coagulation; Blood specimen; Cells; Center for Translational Science Activities; Clinical; Clinical Sciences; Consent; Data; Data Analyses; Databases; Enrollment; Ensure; Gender; Glucose; Goals; Housing; Human; Instruction; Lead; Lipids; Metabolic; Metabolic syndrome; Methods; Molecular Medicine; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Participant; Patient Education; Patients; Process; Prospective Studies; RNA Sequences; Recruitment Activity; Registries; Research; Research Design; Research Personnel; Research Project Grants; Risk; Sample Size; Services; Statistical Data Interpretation; Thrombosis; Tissues; Translational Research; Universities; Utah; Wing; Work; arm; data management; diabetes management; experience; inclusion criteria; insight; meetings; next generation; patient responsibilities; programs; software development; statistics

PROJECT SUMMARY (See instructions): The primary responsibility of the Patient Enrollment and Data Analysis Core (Core B) is to identify and recruit healthy lean control subjects as well as patients with type 2 diabetes and obesity for Projects 1-4 and provide specialized data analysis support for the University of Utah Molecular Medicine Translational Research Center in Thrombosis (U2M2-TRCT). A team of investigators with expertise in thrombosis and metabolic syndromes will lead Core B. This core also includes a clinical coordinator, database manager, and investigators with experience in statistics and bioinformatics. Core B will directly interact with Core C regarding isolation of human platelets from patients with metabolic syndromes and provide support for all four research projects. Patients enrolled through Project 3 will be identified and recruited by Core C using successful methods described in the Core description. The Core will utilize the University of Utah Clinical Center in Translational Science (CCTS) to enhance patient enrollment and study initiation. Core B will be responsible for entering patient data and management of the U-STAR (The Utah Study of Translational Science And Research Registry) database. In addition to recruiting, enrolling, and managing data, Core B will provide statistical and bioinformatics support for all of the projects. The statistics wing will provide sample size and power calculations, assist with study design, and analyze experimental data. The bioinformatics arm will provide support for the next-generation RNA-sequencing studies proposed by U2M2-TRCT investigators. This includes data interpretation, statistical support, and software development. The services provided by Core B, which is centrally located and readily available to all U2M2-TRCT participants, will ensure that enrollment goals are met and exceeded and that data analysis occurs seamlessly within the program.

项目摘要（参见说明）： 患者入组和数据分析核心（核心 B）的主要职责是为项目 1-4 识别和招募健康瘦对照受试者以及 2 型糖尿病和肥胖患者，并为犹他大学血栓形成分子医学转化研究中心 (U2M2-TRCT) 提供专业数据分析支持。具有血栓形成和代谢专业知识的研究人员团队 综合征将领导核心 B。该核心还包括临床协调员、数据库管理员以及具有统计学和生物信息学经验的研究人员。核心 B 将与核心 C 直接互动，从代谢综合征患者中分离人血小板，并为所有四个研究项目提供支持。通过项目 3 入组的患者将由 Core C 使用以下方法进行识别和招募： 核心描述中描述了成功的方法。该核心将利用犹他大学转化科学临床中心 (CCTS) 来加强患者入组和研究启动。核心 B 将负责输入患者数据并管理 U-STAR（犹他州转化科学研究登记处）数据库。除了招募、注册和管理数据之外，核心 B 将为所有项目提供统计和生物信息学支持。统计部门将提供样本量和功效计算，协助研究设计并分析实验数据。生物信息学部门将为 U2M2-TRCT 研究人员提出的下一代 RNA 测序研究提供支持。这包括数据解释、统计支持和软件开发。这 核心 B 提供的服务位于中心位置，可供所有 U2M2-TRCT 参与者随时使用，将确保达到并超过招生目标，并确保数据分析在计划内无缝进行。