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.
Highlights
To develop more targeted diagnostic and treatment methods to improve outcomes in autism spectrum disorder (ASD) (Loth et al, 2016), the scientific field must address the current lack of reliable and sensitive objective measures that inform treatment target engagement or subgroup identification (Jeste et al, 2015; McPartland, 2017; Sahin et al, 2018; Ewen et al, 2019)
We articulate the standard operating protocols developed by the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) Data Acquisition and Analytic Core (DAAC) related to: (1) the design and implementation of multi-site experimental protocols and (2) the quality control (QC) processes related to rigorous, scientifically valid, and replicable procedures used for data acquisition
To oversee consistent application of scientific standards and methodological rigor for data acquisition, processing, and analytics, we developed standards of work that reflect the logistics of multi-site research, and the need for well-articulated, transparent processes that can be implemented by the scientific community in future clinical trials of children with ASD and other neurodevelopmental disorders
Summary
For each biomarker methodology in the Main Study, detailed acquisition protocols and manuals of operations were created to serve as the technical record, training manual, and protocol for acquisition (Naples et al, 2018; Sabatos-DeVito et al, 2018; Shic et al, 2018; Webb et al, 2018) These served as the primary training documents for the Site staff to guide data acquisition and addressed counterbalancing, experimental acquisition, equipment and setup, protocol when the child was present, site staff roles, and data logs. EEG Post-session, acquisition QC was deemed valid if the participant had average or excellent EEG cap placement (both as reported by the site and validated via images of the participant), had completed 50% (out of 3 × 1 min blocks) of the EEG Resting State experiment (from the EEG logs), and if the EEG recording file was readable with the expected experimental markers (Santhosh et al, 2018). The full ET Run Log was reviewed alongside the video recording to ensure that the protocol was being followed and that appropriate behavioral supports were being utilized
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