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.
Publisher Copyright:
© Copyright © 2020 McPartland, Bernier, Jeste, Dawson, Nelson, Chawarska, Earl, Faja, Johnson, Sikich, Brandt, Dziura, Rozenblit, Hellemann, Levin, Murias, Naples, Platt, Sabatos-DeVito, Shic, Senturk, Sugar, Webb and 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 -