Frontiers in Integrative Neuroscience (Feb 2020)
Biomarker Acquisition and Quality Control for Multi-Site Studies: The Autism Biomarkers Consortium for Clinical Trials
- Sara Jane Webb,
- Sara Jane Webb,
- Frederick Shic,
- Frederick Shic,
- Michael Murias,
- Catherine A. Sugar,
- Catherine A. Sugar,
- Catherine A. Sugar,
- Adam J. Naples,
- Erin Barney,
- Heather Borland,
- Gerhard Hellemann,
- Scott Johnson,
- Minah Kim,
- April R. Levin,
- April R. Levin,
- Maura Sabatos-DeVito,
- Megha Santhosh,
- Damla Senturk,
- Damla Senturk,
- James Dziura,
- Raphael A. Bernier,
- Raphael A. Bernier,
- Raphael A. Bernier,
- Katarzyna Chawarska,
- Geraldine Dawson,
- Susan Faja,
- Susan Faja,
- Shafali Jeste,
- Shafali Jeste,
- James McPartland,
- the Autism Biomarkers Consortium for Clinical Trials,
- Adham Atyabi,
- Madeline Aubertine,
- Carter Carlos,
- Shou-An A Chang,
- Scott Compton,
- Kelsey Dommer,
- Alyssa Gateman,
- Simone Hasselmo,
- Bailey Heit,
- Toni Howell,
- Ann Harris,
- Kathryn Hutchins,
- Julie Holub,
- Beibin Li,
- Samantha Major,
- Samuel Marsan,
- Takumi McAllister,
- Andriana S. Méndez Leal,
- Lisa Nanamaker,
- Charles A. Nelson,
- Helen Seow,
- Dylan Stahl,
- Andrew Yuan
Affiliations
- Sara Jane Webb
- Center on Child Health, Behavior, and Development, Seattle Children’s Research Institute, Seattle, WA, United States
- Sara Jane Webb
- Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, United States
- Frederick Shic
- Center on Child Health, Behavior, and Development, Seattle Children’s Research Institute, Seattle, WA, United States
- Frederick Shic
- Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, United States
- Michael Murias
- Duke Center for Autism and Brain Development, Duke University, Durham, NC, United States
- Catherine A. Sugar
- Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, United States
- Catherine A. Sugar
- Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, United States
- Catherine A. Sugar
- Department of Statistics, University of California, Los Angeles, Los Angeles, CA, United States
- Adam J. Naples
- Yale Child Study Center, Yale University, New Haven, CT, United States
- Erin Barney
- Center on Child Health, Behavior, and Development, Seattle Children’s Research Institute, Seattle, WA, United States
- Heather Borland
- Center on Child Health, Behavior, and Development, Seattle Children’s Research Institute, Seattle, WA, United States
- Gerhard Hellemann
- Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, United States
- Scott Johnson
- Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, United States
- Minah Kim
- Center on Child Health, Behavior, and Development, Seattle Children’s Research Institute, Seattle, WA, United States
- April R. Levin
- Department of Neurology, Boston Children’s Hospital, Boston, MA, United States
- April R. Levin
- 0Harvard Medical School, Harvard University, Boston, MA, United States
- Maura Sabatos-DeVito
- Duke Center for Autism and Brain Development, Duke University, Durham, NC, United States
- Megha Santhosh
- Center on Child Health, Behavior, and Development, Seattle Children’s Research Institute, Seattle, WA, United States
- Damla Senturk
- Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, United States
- Damla Senturk
- Department of Statistics, University of California, Los Angeles, Los Angeles, CA, United States
- James Dziura
- Yale Child Study Center, Yale University, New Haven, CT, United States
- Raphael A. Bernier
- Center on Child Health, Behavior, and Development, Seattle Children’s Research Institute, Seattle, WA, United States
- Raphael A. Bernier
- Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, United States
- Raphael A. Bernier
- 1Center on Human Development and Disability, University of Washington, Seattle, WA, United States
- Katarzyna Chawarska
- Yale Child Study Center, Yale University, New Haven, CT, United States
- Geraldine Dawson
- Duke Center for Autism and Brain Development, Duke University, Durham, NC, United States
- Susan Faja
- 0Harvard Medical School, Harvard University, Boston, MA, United States
- Susan Faja
- 2Department of Pediatrics, Boston Children’s Hospital, Boston, MA, United States
- Shafali Jeste
- Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, United States
- Shafali Jeste
- 3Department of Neurology, University of California, Los Angeles, Los Angeles, CA, United States
- James McPartland
- Yale Child Study Center, Yale University, New Haven, CT, United States
- the Autism Biomarkers Consortium for Clinical Trials
- Adham Atyabi
- Madeline Aubertine
- Carter Carlos
- Shou-An A Chang
- Scott Compton
- Kelsey Dommer
- Alyssa Gateman
- Simone Hasselmo
- Bailey Heit
- Toni Howell
- Ann Harris
- Kathryn Hutchins
- Julie Holub
- Beibin Li
- Samantha Major
- Samuel Marsan
- Takumi McAllister
- Andriana S. Méndez Leal
- Lisa Nanamaker
- Charles A. Nelson
- Helen Seow
- Dylan Stahl
- Andrew Yuan
- DOI
- https://doi.org/10.3389/fnint.2019.00071
- Journal volume & issue
-
Vol. 13
Abstract
The objective of the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) is to evaluate a set of lab-based behavioral video tracking (VT), electroencephalography (EEG), and eye tracking (ET) measures for use in clinical trials with children with autism spectrum disorder (ASD). Within the larger organizational structure of the ABC-CT, the Data Acquisition and Analytic Core (DAAC) oversees the standardization of VT, EEG, and ET data acquisition, data processing, and data analysis. This includes designing and documenting data acquisition and analytic protocols and manuals; facilitating site training in acquisition; data acquisition quality control (QC); derivation and validation of dependent variables (DVs); and analytic deliverables including preparation of data for submission to the National Database for Autism Research (NDAR). To oversee consistent application of scientific standards and methodological rigor for data acquisition, processing, and analytics, we developed standard operating procedures that reflect the logistical needs of multi-site research, and the need for well-articulated, transparent processes that can be implemented in future clinical trials. This report details the methodology of the ABC-CT related to acquisition and QC in our Feasibility and Main Study phases. Based on our acquisition metrics from a preplanned interim analysis, we report high levels of acquisition success utilizing VT, EEG, and ET experiments in a relatively large sample of children with ASD and typical development (TD), with data acquired across multiple sites and use of a manualized training and acquisition protocol.
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