AUTHOR=McPartland James C. , Bernier Raphael A. , Jeste Shafali S. , Dawson Geraldine , Nelson Charles A. , Chawarska Katarzyna , Earl Rachel , Faja Susan , Johnson Scott P. , Sikich Linmarie , Brandt Cynthia A. , Dziura James D. , Rozenblit Leon , Hellemann Gerhard , Levin April R. , Murias Michael , Naples Adam J. , Platt Michael L. , Sabatos-DeVito Maura , Shic Frederick , Senturk Damla , Sugar Catherine A. , Webb Sara J. , the Autism Biomarkers Consortium for Clinical Trials TITLE=The Autism Biomarkers Consortium for Clinical Trials (ABC-CT): Scientific Context, Study Design, and Progress Toward Biomarker Qualification JOURNAL=Frontiers in Integrative Neuroscience VOLUME=14 YEAR=2020 URL=https://www.frontiersin.org/journals/integrative-neuroscience/articles/10.3389/fnint.2020.00016 DOI=10.3389/fnint.2020.00016 ISSN=1662-5145 ABSTRACT=

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.