Administrative Core

行政核心

• 批准号: 10083885
• 负责人: James Charles McPartland
• 金额: $ 112.42万
• 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: 2015-07-17 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10083885
• 关键词: 5 year old; Agreement; Back; Biological Assay; Biological Markers; Blood; Blood specimen; Characteristics; Child; Clinical; Clinical Research; Clinical Trials; Cognitive; Collection; Communication; Data; Data Analyses; Data Analytics; Data Collection; Databases; Development; Discrimination; Documentation; Electroencephalography; Enrollment; Ensure; Ethics; Excision; Face; Feasibility Studies; Feedback; Follow-Up Studies; Generations; Goals; Good Clinical Practice; Heterogeneity; Human; Individual; Institutional Review Boards; Lead; Leadership; Maintenance; Manuals; Measures; Methodology; Monitor; Morphologic artifacts; National Institute of Mental Health; Neurodevelopmental Disorder; Nursery Schools; Occupational activity of managing finances; Persons; Phase; Procedures; Property; Protocols documentation; Psychometrics; Quality Control; Reporting; Research; Research Design; Research Personnel; Sample Size; Sampling; Secure; Site; Site Visit; Social Functioning; Source; Stratification; Testing; Time; TimeLine; To specify; U-Series Cooperative Agreements; United States National Institutes of Health; Update; Work; aged; autism spectrum disorder; autistic children; base; clinical trial enrollment; cohort; computerized data processing; data acquisition; data integration; data management; data quality; data sharing; data standards; data warehouse; design; experience; file format; indexing; informatics infrastructure; meetings; member; middle childhood; oculomotor; operation; programs; recruit; social communication; visual tracking

Project Summary/Abstract The ongoing goal of the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is to establish electroencephalography (EEG) and eye-tracking (ET) biomarkers that can be used for stratification and/or as sensitive and reliable objective assays related to social function in autism spectrum disorder (ASD) clinical trials. This renewal application seeks to further validate promising measures through three studies designed to enhance and extend the original ABC-CT study: (1) a confirmation study of the original findings in a new cohort using similar design (T1: Baseline, T2: 6 weeks post baseline, T3: 24 weeks post baseline) and sample size/characteristics (200 with ASD, 200 with typical development (TD)); (2) a follow-up study of the original cohort (N=399) to re-administer the biomarker and clinical batteries 2.5-4 years after original ABC-CT enrollment; (3) a feasibility study of parallel EEG and ET biomarkers in preschool-aged (3-5-year-old) children (25 with ASD, 25 with TD). The biomarker and clinical batteries measure key facets of social-communication in ASD using well- validated paradigms appropriate for the intended developmental and cognitive range. The study will rely on the same leadership and five Collaborating Implementation Sites (“Sites”) from the first phase, all highly experienced in multi-site collaborative clinical research using the proposed clinical, EEG, and ET methodologies. The Data Coordinating Core (DCC) will provide a secure informatics infrastructure for communication and data integration across the consortium to ensure organized data management, quality control, and reliable upload to the National Database for Autism Research (NDAR) and NIH Data Repositories. The Data Acquisition and Analysis Core (DAAC) will oversee consistent use of scientific standards and methodological rigor for data acquisition, processing, and analytics. The Administrative Core will oversee the operations of the sites, the DCC, and the DAAC to ensure methodologically and ethically rigorous, efficient completion of study aims and to coordinate with federal partners in this cooperative agreement by: 1) Coordinating communication and data sharing to manage all aspects of the project, including recruitment and data collection, data management and quality control, standardization of data acquisition and processing, analytic planning, and financial management; 2) Administering the consortium project across all sites and cores in terms of managing the central institutional review board, developing and disseminating Standard Operating Procedures, implementing Good Clinical Practice, maintaining research fidelity, overseeing quality control, and planning timely upload to NIH/NIMH Data Repositories; 3) Maintaining appropriate communication and integrating feedback from federal partners, executing the finalized protocol as per the collaborative agreement, and planning Steering Committee meetings and annual in-person meetings.

项目总结/摘要 自闭症生物标志物临床试验联盟（ABC-CT）的持续目标是建立 脑电描记术（EEG）和眼动追踪（ET）生物标志物，其可用于分层和/或作为脑电描记术（EEG）和眼动追踪（ET）生物标志物。 在自闭症谱系障碍（ASD）临床试验中与社会功能相关的敏感和可靠的客观测定。 这一延期申请旨在通过三项研究进一步验证有希望的措施， 增强和扩展原始ABC-CT研究：（1）在新队列中对原始发现进行确认研究 使用相似设计（T1：基线，T2：基线后6周，T3：基线后24周）和样本 大小/特征（200例ASD，200例典型发育（TD））;（2）原始队列的随访研究 （N = 399）在初始ABC-CT入组后2.5 - 4年重新给予生物标志物和临床组合;（3）a 在学龄前（3 - 5岁）儿童（25名ASD，25名 TD）。生物标志物和临床电池测量ASD中社交沟通的关键方面， 适用于预期发展和认知范围的验证范式。这项研究将依赖于 相同的领导层和第一阶段的五个协作实施站点（“站点”），所有站点都经验丰富 使用拟议的临床、EEG和ET方法进行多地点协作临床研究。数据 协调核心（DCC）将为通信和数据集成提供安全的信息学基础设施 以确保有组织的数据管理，质量控制和可靠的上传到国家 自闭症研究数据库（NDAR）和NIH数据库。数据采集和分析核心 （DAAC）将监督科学标准的一致使用和数据采集方法的严格性， 处理和分析。行政核心将监督网站、DCC和 DAAC确保在方法和道德上严格，有效地完成研究目标，并协调 与本合作协议中的联邦合作伙伴通过：1）协调通信和数据共享， 管理项目的各个方面，包括招聘和数据收集、数据管理和质量 控制、数据采集和处理的标准化、分析规划和财务管理; 2） 在管理中央机构方面，管理所有地点和核心的联合体项目 审查委员会，制定和传播标准操作规程，实施良好临床试验 实践，保持研究保真度，监督质量控制，并计划及时上传到NIH/NIMH数据 3）保持适当的沟通并整合来自联邦合作伙伴的反馈， 根据合作协议执行最终议定书，并规划指导委员会会议 年度面对面会议。