TY - JOUR
T1 - The Autism Biomarkers Consortium for Clinical Trials (ABC-CT)
T2 - Scientific Context, Study Design, and Progress Toward Biomarker Qualification
AU - the Autism Biomarkers Consortium for Clinical Trials
AU - McPartland, James C.
AU - Bernier, Raphael A.
AU - Jeste, Shafali S.
AU - Dawson, Geraldine
AU - Nelson, Charles A.
AU - Chawarska, Katarzyna
AU - Earl, Rachel
AU - Faja, Susan
AU - Johnson, Scott P.
AU - Sikich, Linmarie
AU - Brandt, Cynthia A.
AU - Dziura, James D.
AU - Rozenblit, Leon
AU - Hellemann, Gerhard
AU - Levin, April R.
AU - Murias, Michael
AU - Naples, Adam J.
AU - Platt, Michael L.
AU - Sabatos-DeVito, Maura
AU - Shic, Frederick
AU - Senturk, Damla
AU - Sugar, Catherine A.
AU - Webb, Sara J.
N1 - Funding Information:
We extend gratitude to all of the families and participants who participated in this research. In addition, we thank the ABC-CT Project Management Team, the ABC-CT External Advisory Board, NIH project scientists, and colleagues from the FNIH Biomarkers Consortium. Funding. Support was provided by NIMH U19 MH108206 (JM), the Autism Biomarkers Consortium for Clinical Trials.
PY - 2020/4/9
Y1 - 2020/4/9
N2 - 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.
AB - 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.
KW - EEG
KW - ERP
KW - autism spectrum disorder
KW - biomarker
KW - clinical trial methodology/study design
KW - eye-tracking
KW - neuroscience
UR - http://www.scopus.com/inward/record.url?scp=85084002195&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85084002195&partnerID=8YFLogxK
U2 - 10.3389/fnint.2020.00016
DO - 10.3389/fnint.2020.00016
M3 - Article
C2 - 32346363
AN - SCOPUS:85084002195
VL - 14
JO - Frontiers in Integrative Neuroscience
JF - Frontiers in Integrative Neuroscience
SN - 1662-5145
M1 - 16
ER -