The Autism Biomarkers Consortium for Clinical Trials (ABC-CT): Scientific Context, Study Design, and Progress Toward Biomarker Qualification

被引：86

作者：

McPartland, James C. ^{[1
]}

Bernier, Raphael A. ^{[2
,3
]}

Jeste, Shafali S. ^{[4
]}

Dawson, Geraldine ^{[5
]}

Nelson, Charles A. ^{[6
,7
,8
]}

Chawarska, Katarzyna ^{[1
]}

Earl, Rachel ^{[9
]}

Faja, Susan ^{[6
,7
,8
]}

Johnson, Scott P. ^{[4
]}

Sikich, Linmarie ^{[5
]}

Brandt, Cynthia A. ^{[10
]}

Dziura, James D. ^{[10
]}

Rozenblit, Leon ^{[11
]}

Hellemann, Gerhard ^{[4
]}

Levin, April R. ^{[6
,7
,8
]}

Murias, Michael ^{[12
]}

Naples, Adam J. ^{[1
]}

Platt, Michael L. ^{[13
]}

Sabatos-DeVito, Maura ^{[5
]}

Shic, Frederick ^{[2
,14
]}

Senturk, Damla ^{[4
]}

Sugar, Catherine A. ^{[4
]}

Webb, Sara J. ^{[2
,3
]}

机构：

[1] Yale Child Study Ctr, New Haven, CT USA

[2] Seattle Childrens Hosp, Seattle Childrens Res Inst, Ctr Child Hlth Behav & Dev, Seattle, WA USA

[3] Univ Washington, Sch Med, Dept Psychiat & Behav Sci, Seattle, WA 98195 USA

[4] Univ Calif Los Angeles, Los Angeles, CA USA

[5] Duke Univ, Duke Ctr Autism & Brain Dev, Durham, NC USA

[6] Boston Childrens Hosp, Boston, MA USA

[7] Harvard Med Sch, Boston, MA 02115 USA

[8] Harvard Univ, Boston, MA 02115 USA

[9] Univ Washington, Ctr Human Dev & Disabil, Seattle, WA 98195 USA

[10] Yale Univ, New Haven, CT USA

[11] Prometheus Res LLC, New Haven, CT USA

[12] Northwestern Univ, Chicago, IL 60611 USA

[13] Univ Penn, Philadelphia, PA 19104 USA

[14] Univ Washington, Sch Med, Dept Pediat, Seattle, WA 98195 USA

来源：

FRONTIERS IN INTEGRATIVE NEUROSCIENCE | 2020年 / 14卷

关键词：

autism spectrum disorder; biomarker; neuroscience; clinical trial methodology; study design; EEG; ERP; eye-tracking; EVENT-RELATED POTENTIALS; BIOLOGICAL MOTION;

D O I：

10.3389/fnint.2020.00016

中图分类号：

B84 [心理学]; C [社会科学总论]; Q98 [人类学];

学科分类号：

03 ; 0303 ; 030303 ; 04 ; 0402 ;

摘要：

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.

引用

页数：7

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