Clinical research in neurodevelopmental disorders remains reliant upon clinician and caregiver measures. Limitations of these approaches indicate a need for objective, quantitative, and reliable biomarkers to advance clinical research. Extant research suggests the potential utility of multiple candidate biomarkers; however, effective application of these markers in trials requires additional understanding of replicability, individual differences, and intra-individual stability over time. The Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is a multi-site study designed to investigate a battery of electrophysiological (EEG) and eye-tracking (ET) indices as candidate biomarkers for autism spectrum disorder (ASD). The study complements published biomarker research through: inclusion of large, deeply phenotyped cohorts of children with ASD and typical development; a longitudinal design; a focus on well-evidenced candidate biomarkers harmonized with an independent sample; high levels of clinical, regulatory, technical, and statistical rigor; adoption of a governance structure incorporating diverse expertise in the ASD biomarker discovery and qualification process; prioritization of open science, including creation of a repository containing biomarker, clinical, and genetic data; and use of economical and scalable technologies that are applicable in developmental populations and those with special needs. The ABC-CT approach has yielded encouraging results, with one measure accepted into the FDA’s Biomarker Qualification Program to date. Through these advances, the ABC-CT and other biomarker studies in progress hold promise to deliver novel tools to improve clinical trials research in ASD.

神经发育障碍的临床研究仍然依赖于临床医生和护理人员的措施。这些方法的局限性表明需要客观、定量和可靠的生物标志物来推进临床研究。现有研究表明多种候选生物标志物的潜在效用；然而，这些标志物在试验中的有效应用需要对可重复性、个体差异和个体内稳定性随时间的推移有更多的了解。自闭症生物标志物临床试验联盟 (ABC-CT) 是一项多站点研究，旨在研究一系列电生理 (EEG) 和眼动追踪 (ET) 指数作为自闭症谱系障碍 (ASD) 的候选生物标志物。该研究通过以下方式补充了已发表的生物标志物研究：具有 ASD 和典型发育的深度表型队列；纵向设计；专注于与独立样本协调一致的证据充分的候选生物标志物；高水平的临床、监管、技术和统计严谨性；在 ASD 生物标志物的发现和鉴定过程中采用融合了不同专业知识的治理结构；优先考虑开放科学，包括创建一个包含生物标志物、临床和遗传数据的存储库；并使用适用于发育人群和有特殊需求的经济且可扩展的技术。ABC-CT 方法产生了令人鼓舞的结果，迄今为止，一项措施已被 FDA 的生物标志物资格计划接受。通过这些进步，