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. 2020 Feb 7:13:71.
doi: 10.3389/fnint.2019.00071. eCollection 2019.

Biomarker Acquisition and Quality Control for Multi-Site Studies: The Autism Biomarkers Consortium for Clinical Trials

Sara Jane Webb  1   2 , Frederick Shic  1   3 , Michael Murias  4 , Catherine A Sugar  5   6   7 , Adam J Naples  8 , Erin Barney  1 , Heather Borland  1 , Gerhard Hellemann  6 , Scott Johnson  6 , Minah Kim  1 , April R Levin  9   10 , Maura Sabatos-DeVito  4 , Megha Santhosh  1 , Damla Senturk  5   7 , James Dziura  8 , Raphael A Bernier  1   2   11 , Katarzyna Chawarska  8 , Geraldine Dawson  4 , Susan Faja  10   12 , Shafali Jeste  6   13 , James McPartland  8 ; Autism Biomarkers Consortium for Clinical Trials
Collaborators, Affiliations

Biomarker Acquisition and Quality Control for Multi-Site Studies: The Autism Biomarkers Consortium for Clinical Trials

Sara Jane Webb et al. Front Integr Neurosci. .

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.

Keywords: EEG; autism spectrum disorder; biomarkers; clinical trial methods; eye tracking; guidelines; video tracking.

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Figures

FIGURE 1
FIGURE 1
Video tracking of child physical movement. Room setup for PCFP with overlay of video tracking of movement of child 1 (A) and 2 (B).
FIGURE 2
FIGURE 2
EEG session. (A) Participant exploring the EEG equipment; (B) preparing for the net; (C) net placement; (D) experimenter setup for monitoring experiment, data, and child attention; (E) child watching video while setup is finalized; and (F) child attending to instruction screen for experiment. Written consent was obtained from the adult experimenter and the parents of the child shown; the child provided assent.
FIGURE 3
FIGURE 3
ET session. (A) Preparing to enter ET room and ET sticker placement; (B) overhead view of room with participant and experimenter; (C) experimenter setup for monitoring experiment, data, and child attention; and (D) child attention to experiment. Written consent was obtained from the adult experimenter and the parents of the child shown in the images; the child provided assent.
See this image and copyright information in PMC

References

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