AUTHOR=Ewen Joshua B. , Sweeney John A. , Potter William Z. 

TITLE=Conceptual, Regulatory and Strategic Imperatives in the Early Days of EEG-Based Biomarker Validation for Neurodevelopmental Disabilities

JOURNAL=Frontiers in Integrative Neuroscience

VOLUME=13

YEAR=2019

URL=https://www.frontiersin.org/journals/integrative-neuroscience/articles/10.3389/fnint.2019.00045

DOI=10.3389/fnint.2019.00045

ISSN=1662-5145

ABSTRACT=<p>Biological treatment development for syndromal neuropsychiatric conditions such as autism has seen slow progress for decades. Speeding drug discovery may result from the judicious development and application of biomarker measures of brain function to select patients for clinical trials, to confirm target engagement and to optimize drug dose. For neurodevelopmental disorders, electrophysiology (EEG) offers considerable promise because of its ability to monitor brain activity with high temporal resolution and its more ready application for pediatric populations relative to MRI. Here, we discuss conceptual/definitional issues related to biomarker development, discuss practical implementation issues, and suggest preliminary guidelines for validating EEG approaches as biomarkers with a context of use in neurodevelopmental disorder drug development.</p>