Clinical Core

临床核心

• 批准号: 8860082
• 负责人: STEPHANIE S O'MALLEY
• 金额: $ 26.92万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-06-01 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8860082
• 关键词: Address; Alcohol dependence; Alcoholism; Biometry; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Clinical assessments; Collection; Communities; Data; Data Analyses; Data Quality; Development; Enrollment; Funding; Future; Genetic; Goals; Grant; Image; Individual; Meta-Analysis; Methods; Monitor; National Institute on Alcohol Abuse and Alcoholism; Participant; Pilot Projects; Principal Investigator; Protocols documentation; Randomized; Recruitment Activity; Reporting; Research Personnel; Resources; Risk; Structure; Technology; Training; Update; alcohol research; alcoholism therapy; data management; design; meetings; success; tool; translational neuroscience

The CTNA Clinical Core serves an important function as the central resource for the diverse clinical projects and pilots. It represents the distinct advantage of an Alcohol Research Center over a cluster of individual grants. The opportunity to fund a central facility with a distinguished leader provides a programmatic method to define needs and assign resources to address central issues. The central components of the Clinical Core are oversight of subject recruitment and clinical assessments for all clinical projects, data management and analysis. The specific aims for this core are: A. Centralized monitoring of subject recruitment to: 1) Enhance the efficiency of enrollment into each project, including pilots; and 2) Update the Principal Investigators (PIs), the Scientific Advisory Board, and the Data Safety Monitoring Board of progress on the protocols B. Central oversight of assessments to: 1) Provide efficiency in training and assessment; 2) Maintain consistency in the administration of assessments; 3) Enhance the ability of investigators to pool data across studies; 4) Insure that validated and current assessment tools are used; and 5) Support secondary analyses utilizing core assessments. C. Central provision of Data Management and Biostatistics support to: 1) Provide design and analytical expertise to meet the goals of the CTNA scientific agenda; 2) Provide state-of-the-art methods for data management; 3) Generate randomization lists and assess randomization implementation; 4) Interface with specialized data analysis expertise related to particular technologies associated with the CTNA, including genetics and imaging; 5) Prepare reports related to the progress of clinical studies for the Data Safety Monitoring Board; and 6) Provide statistical support for all investigators.

CTNA 临床核心作为各种临床项目和试点的中心资源发挥着重要作用。它代表了酒精研究中心相对于一系列个人资助的独特优势。由杰出领导者资助中央设施的机会提供了一种确定需求和分配资源来解决核心问题的程序化方法。临床核心的核心组成部分是监督所有临床项目的受试者招募和临床评估、数据管理和分析。该核心的具体目标是： A. 集中监控受试者招募，以： 1）提高每个项目（包括试点）的招募效率； 2) 向首席研究员 (PI)、科学顾问委员会和数据安全监测委员会通报协议进展情况 B. 对评估进行中央监督，以： 1) 提高培训和评估的效率； 2）保持评估管理的一致性； 3）增强研究者汇集跨研究数据的能力； 4) 确保使用经过验证的最新评估工具； 5) 支持利用核心评估进行二次分析。 C. 集中提供数据管理和生物统计支持，以： 1) 提供设计和分析专业知识，以实现 CTNA 科学议程的目标； 2）提供最先进的数据管理方法； 3) 生成随机化名单并评估随机化实施情况； 4) 与与 CTNA 相关的特定技术（包括遗传学和成像）相关的专业数据分析专家对接； 5) 为数据安全监察委员会准备临床研究进展相关报告； 6) 为所有研究者提供统计支持。