TY - JOUR
T1 - Biomarker Acquisition and Quality Control for Multi-Site Studies
T2 - The Autism Biomarkers Consortium for Clinical Trials
AU - the Autism Biomarkers Consortium for Clinical Trials
AU - Webb, Sara Jane
AU - Shic, Frederick
AU - Murias, Michael
AU - Sugar, Catherine A.
AU - Naples, Adam J.
AU - Barney, Erin
AU - Borland, Heather
AU - Hellemann, Gerhard
AU - Johnson, Scott
AU - Kim, Minah
AU - Levin, April R.
AU - Sabatos-DeVito, Maura
AU - Santhosh, Megha
AU - Senturk, Damla
AU - Dziura, James
AU - Bernier, Raphael A.
AU - Chawarska, Katarzyna
AU - Dawson, Geraldine
AU - Faja, Susan
AU - Jeste, Shafali
AU - McPartland, James
N1 - Funding Information:
A special thanks to all of the families and participants who join with us in this effort. In addition, we thank our external advisory board, NIH scientific partners, and the FNIH Biomarkers Consortium. Additional important contributions were provided by members of the ABC-CT consortium including: Adham Atyabi Ph.D., 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. M?ndez Leal, Lisa Nanamaker, Charles A. Nelson, Helen Seow, Dylan Stahl, and Andrew Yuan. We refer to a number of experiments as well as support documents detailing our standard operation procedures and manuals of operation for the ABC-CT Feasibility phase and Main Study phase; these documents can be accessed by request from the principal investigator (james.mcpartland@yale.edu) and additional project information can be found via our website https:// medicine.yale.edu/ycci/researchers/autism/. Funding. Support was provided by the U19 Consortium on Biomarker and Outcome Measures of Social Impairment for use in Clinical Trials in Autism Spectrum Disorder (ABC-CT) NIMH U19 MH108206 (JM).
Funding Information:
Conflict of Interest: EB was employed at Seattle Children’s Research Institute at the time of the drafting of this manuscript; she is currently of Cogstate (www.cogstate.com). RB was employed at the University of Washington at the time of the submission of this manuscript; he is currently employed by Apple. MK was at Seattle Children’s Research Institute at the time of the drafting of this manuscript; she is currently at University of Virginia. MM was at Duke University at the time of the drafting of this manuscript; he is currently at Northwestern University. GD is on the Scientific Advisory Boards of Janssen Research and Development, Akili, Inc., LabCorp, Inc., and Roche Pharmaceutical Company, a consultant for Apple, Inc., Gerson Lehrman Group, and Axial Ventures, has received grant funding from Janssen Research and Development, is CEO of DASIO, LLC, which focuses on digital phenotyping tools, and receives book royalties from Guilford Press, Springer, and Oxford University Press. JM has received funding from Janssen Research and Development and receives book Royalties from Guilford, Springer, and Lambert Press. FS consults for Roche Pharmaceutical Company and Janssen Research and Development.
Publisher Copyright:
© Copyright © 2020 Webb, Shic, Murias, Sugar, Naples, Barney, Borland, Hellemann, Johnson, Kim, Levin, Sabatos-DeVito, Santhosh, Senturk, Dziura, Bernier, Chawarska, Dawson, Faja, Jeste, McPartland and the Autism Biomarkers Consortium for Clinical Trials.
PY - 2020/2/7
Y1 - 2020/2/7
N2 - 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.
AB - 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.
KW - EEG
KW - autism spectrum disorder
KW - biomarkers
KW - clinical trial methods
KW - eye tracking
KW - guidelines
KW - video tracking
UR - http://www.scopus.com/inward/record.url?scp=85079750216&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85079750216&partnerID=8YFLogxK
U2 - 10.3389/fnint.2019.00071
DO - 10.3389/fnint.2019.00071
M3 - Article
C2 - 32116579
AN - SCOPUS:85079750216
SN - 1662-5145
VL - 13
JO - Frontiers in Integrative Neuroscience
JF - Frontiers in Integrative Neuroscience
M1 - 71
ER -