Conceptual, Regulatory and Strategic Imperatives in the Early Days of EEG-Based Biomarker Validation for Neurodevelopmental Disabilities
- 1Neurology and Developmental Medicine, Kennedy Krieger Institute, United States
- 2Johns Hopkins University, United States
- 3University of Cincinnati, United States
- 4National Institute of Mental Health (NIMH), United States
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.
Keywords: biomarker, EEG, autism, ADHD, Validation, qualification, Neuropsychiatry
Received: 15 May 2019;
Accepted: 06 Aug 2019.
Edited by:Timothy Roberts, Children's Hospital of Philadelphia, United States
Reviewed by:Alexandra Key, Vanderbilt University Medical Center, United States
Paige Siper, Icahn School of Medicine at Mount Sinai, United States
Copyright: © 2019 Ewen, Sweeney and Potter. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Dr. Joshua B. Ewen, Kennedy Krieger Institute, Neurology and Developmental Medicine, Baltimore, 21230, MD, United States, firstname.lastname@example.org