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

Publication ,  Journal Article
McPartland, JC; Bernier, RA; Jeste, SS; Dawson, G; Nelson, CA; Chawarska, K; Earl, R; Faja, S; Johnson, SP; Sikich, L; Brandt, CA; Dziura, JD ...
Published in: Front Integr Neurosci
2020

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.

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Published In

Front Integr Neurosci

DOI

ISSN

1662-5145

Publication Date

2020

Volume

14

Start / End Page

16

Location

Switzerland

Related Subject Headings

  • 3209 Neurosciences
  • 3202 Clinical sciences
  • 3101 Biochemistry and cell biology
  • 1702 Cognitive Sciences
  • 1701 Psychology
  • 1109 Neurosciences
 

Citation

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McPartland, J. C., Bernier, R. A., Jeste, S. S., Dawson, G., Nelson, C. A., Chawarska, K., … Autism Biomarkers Consortium for Clinical Trials, . (2020). The Autism Biomarkers Consortium for Clinical Trials (ABC-CT): Scientific Context, Study Design, and Progress Toward Biomarker Qualification. Front Integr Neurosci, 14, 16. https://doi.org/10.3389/fnint.2020.00016
McPartland, James C., Raphael A. Bernier, Shafali S. Jeste, Geraldine Dawson, Charles A. Nelson, Katarzyna Chawarska, Rachel Earl, et al. “The Autism Biomarkers Consortium for Clinical Trials (ABC-CT): Scientific Context, Study Design, and Progress Toward Biomarker Qualification.Front Integr Neurosci 14 (2020): 16. https://doi.org/10.3389/fnint.2020.00016.
McPartland JC, Bernier RA, Jeste SS, Dawson G, Nelson CA, Chawarska K, et al. The Autism Biomarkers Consortium for Clinical Trials (ABC-CT): Scientific Context, Study Design, and Progress Toward Biomarker Qualification. Front Integr Neurosci. 2020;14:16.
McPartland, James C., et al. “The Autism Biomarkers Consortium for Clinical Trials (ABC-CT): Scientific Context, Study Design, and Progress Toward Biomarker Qualification.Front Integr Neurosci, vol. 14, 2020, p. 16. Pubmed, doi:10.3389/fnint.2020.00016.
McPartland JC, Bernier RA, Jeste SS, Dawson G, Nelson CA, Chawarska K, Earl R, Faja S, Johnson SP, Sikich L, Brandt CA, Dziura JD, Rozenblit L, Hellemann G, Levin AR, Murias M, Naples AJ, Platt ML, Sabatos-DeVito M, Shic F, Senturk D, Sugar CA, Webb SJ, Autism Biomarkers Consortium for Clinical Trials. The Autism Biomarkers Consortium for Clinical Trials (ABC-CT): Scientific Context, Study Design, and Progress Toward Biomarker Qualification. Front Integr Neurosci. 2020;14:16.

Published In

Front Integr Neurosci

DOI

ISSN

1662-5145

Publication Date

2020

Volume

14

Start / End Page

16

Location

Switzerland

Related Subject Headings

  • 3209 Neurosciences
  • 3202 Clinical sciences
  • 3101 Biochemistry and cell biology
  • 1702 Cognitive Sciences
  • 1701 Psychology
  • 1109 Neurosciences