학술논문
Biomarker Acquisition and Quality Control for Multi-Site Studies: The Autism Biomarkers Consortium for Clinical Trials
Document Type
article
Author
Sara Jane Webb; Frederick Shic; Michael Murias; Catherine A. Sugar; Adam J. Naples; Erin Barney; Heather Borland; Gerhard Hellemann; Scott Johnson; Minah Kim; April R. Levin; Maura Sabatos-DeVito; Megha Santhosh; Damla Senturk; James Dziura; Raphael A. Bernier; Katarzyna Chawarska; Geraldine Dawson; Susan Faja; 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
Source
Frontiers in Integrative Neuroscience, Vol 13 (2020)
Subject
Language
English
ISSN
1662-5145
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.