Data Acquisition and Analysis Core

项目总结/摘要 该联盟的目标是建立可用作生物标志物和/或敏感可靠的工具。 自闭症谱系障碍（ASD）临床试验中社会损害的客观分析。具体而言，我们的目标是 通过验证（a）结果，加速开发有效的ASD社交障碍治疗方法 对治疗反应进行敏感和可靠评估的指标，以及（B） 脑电图（EEG）和眼动追踪（ET）生物标志物，可用于减少 通过分层的样本，指示早期功效，和/或证明靶标接合。该财团 包括五个合作实施点（“网站”）进行自然，学前教育的纵向研究 (3-5患有ASD和典型发育（TD）的学龄（6-11岁）儿童，智商范围为 50-115.将使用以下方法在三个时间点（T1：基线，T2：6周，T3：24周）对儿童进行评估 临床医生、护理人员和基于实验室（LB）的社交障碍测量，沿着一系列概念性的 相关EEG和ET任务和临床状态的独立评级。数据采集和分析核心 （数据和咨询委员会）将监督科学标准的一致应用和数据收集方法的严格性， 处理和分析。我们提出了合理的采购标准，其中许多是由行业领导者制定的， 这一核心，并在一个基础设施内的创新分析，旨在促进多站点研究。标准 操作程序（SOP）和程序手册（MOPs）将确保清晰、可复制的采购 协议和后处理分析方法，以评估EEG和ET作为临床敏感指标 状态，作为ASD的分层生物标志物，作为敏感和可靠的变化指标，以及与LB- 基于社会沟通行为和护理人员/临床医生评估的措施。数据存取控制器会起作用的 在Admin Core的监督下，与各站点和数据协调核心（DCC）一起， 与联邦和私人合作伙伴在本合作协议中进行协调，以：1）设计和实施 实验方案，以确保标准化的数据采集; 2）设计和实施严谨，科学 有效的、可复制的数据处理和从数据集中去除伪影; 3）设计和实现统计 生物标志物评估的分析，包括：（a）选择、实施和导出EEG和ET生物标志物 和LB测量变量具有良好的性能指标（结构效度，重测信度，稳定性， 和判别效度）;（B）检查EEG和ET生物标志物之间的关系和灵敏度，LB （c）评估临床状态的独立测量、临床医生/护理人员评估和独立测量; ET、EEG和LB指标的纵向变化，以确定这些指标是否为 干预试验。

Project Summary/Abstract The goal of this consortium is to establish tools that can be used as biomarkers and/or sensitive and reliable objective assays of social impairment in autism spectrum disorder (ASD) clinical trials. Specifically, we aim to accelerate the development of effective treatments for social impairment in ASD by validating (a) outcome measures that will be sensitive and reliable assessments of response to treatment and (b) electroencephalography (EEG) and eye-tracking (ET) biomarkers that can be used to reduce heterogeneity of samples via stratification, indicate early efficacy, and/or demonstrate target engagement. The consortium includes five Collaborating Implementation Sites (“Sites”) to conduct a naturalistic, longitudinal study of preschool (3-5 years) and school-aged (6-11 years) children with ASD and typical development (TD) with IQ ranging from 50-115. Children will be assessed across three time points (T1: Baseline, T2: 6 weeks, T3: 24 weeks) using clinician, caregiver, and lab-based (LB) measures of social impairment, along with a battery of conceptually related EEG and ET tasks and independent ratings of clinical status. The Data Acquisition and Analysis Core (DAAC) will oversee consistent application of scientific standards and methodological rigor for data collection, processing, and analytics. We propose well-justified acquisition standards, many developed by field leaders in this Core, and innovative analytics within an infrastructure designed to facilitate multi-site research. Standard Operating Procedures (SOPs) and Manuals of Procedures (MOPs) will ensure clear, replicable acquisition protocols and post-processing analytic approaches to assess EEG and ET as sensitive indicators of clinical status, as stratification biomarkers for ASD, as sensitive and reliable indicators of change, and in relation to LB- based measures of social-communicative behavior and caregiver/clinician assessments. The DAAC will work together with the Sites and the Data Coordinating Core (DCC) under the oversight of the Admin Core and in coordination with federal and private partners in this collaborative agreement to: 1) design and implement experimental protocols to ensure standardized data acquisition; 2) design and implement rigorous, scientifically valid, and replicable data processing of and artifact removal from data sets; 3) design and implement statistical analyses for biomarker evaluation, including: (a) selecting, implementing, and deriving EEG and ET biomarkers and LB measurement variables with good performance metrics (construct validity, test-retest reliability, stability, and discriminant validity); (b) examining the relationship and sensitivity among EEG and ET biomarkers, LB measures, clinician/caregiver assessments, and independent measures of clinical status; (c) evaluating longitudinal change in ET, EEG, and LB measures to identify if these measures will be sensitive measures for intervention trials.