Data Acquisition and Analysis Core

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 在多站点协作临床研究中使用所提出的临床、EEG和ET方法。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。行政核心，协调 与联邦合作伙伴在这一合作协议，将监督网站的运作，DCC，和数据 收购和分析核心（DAAC），以确保在方法和道德上严格，有效地完成 科学目的。在所有研究中，DAAC将（1）完善和实施采购和质量协议 控制EEG和ET措施;（2）更新和实施严格的、科学有效的和可复制的数据 EEG和ET生物标志物协议的处理管道;以及（3）实施统计分析，提供广泛的 基于统计咨询服务，并率先开发新的方法。DAAC依赖于 参与第一阶段的科学贡献者团队，积极参与合作ET，EEG和统计 方法制定，致力于实现联合会的目标。DAAC的教职员工一直在 选择与本项目密切相关的具体和独特的专业知识，并将这些知识用于他们的具体 培训、采购、处理和分析方面的角色。生产性数据流将通过操作获得 管理，包括促进现场采集，DCC数据存储和监控，并建立一个明确的 DAAC可交付成果的时间轴。

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 Administrative Core, in coordination with federal partners in this cooperative agreement, will oversee the operations of the sites, DCC, and Data Acquisition and Analysis Core (DAAC) to ensure methodologically and ethically rigorous, efficient completion of scientific aims. Across all studies, the DAAC will (1) refine and implement the protocols for acquisition and quality control of EEG and ET measures; (2) update and implement rigorous, scientifically valid, and replicable data processing pipelines for EEG and ET biomarker protocols; and (3) implement statistical analyses, provide broad- based statistical consulting services, and spearhead novel methodological development. The DAAC relies upon the team of scientific contributors involved in the first phase and active in collaborative ET, EEG, and statistical methodology development, who are dedicated to the goals of the consortium. DAAC faculty and staff have been selected for specific and unique expertise germane to this project and will put that knowledge toward their specific roles in training, acquisition, processing, and analytics. Productive data flow will be obtained through operations management including facilitating site acquisition, DCC data storage and monitoring, and establishing a clear timeline for DAAC deliverables.