OpportunityTitle: Limited Competition: Consortium on Biomarker and Outcome Measures of Social Impairment for Use in Clinical Trials in Autism Spectrum Disorder (U19 Clinical Trial Not Allowed)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following: Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.  Foreign components, as defined in the NIH Grants Policy Statement, are allowed.  See the funding announcement for the eligibility details
Description: The purpose of this Funding Opportunity Announcement (FOA) is to further validate promising EEG and eye tracking measures that showed promising performance in the recently-completed Autism Biomarkers Consortium for Clinical Trials (ABC-CT) study. The intent of the FOA is to qualify a set of measures that can be used as biomarkers to reduce heterogeneity, and/or as sensitive and reliable objective measures of social impairment in autism spectrum disorders (ASD) clinical trials. The FOA will support a multi-site consortium to conduct a study with three primary aims to replicate and extend previous characterization of the most promising EEG and eye-tracking measures, incorporating suggestions and guidance from the FDA Biomarkers Qualification Program (BQP). A key goal of the Consortium project is to provide a community resource for broad sharing of all data generated including processed/analyzed data, with rapid and timely deposition of data into the National Database for Autism Research (NDAR). All data generated in this project are expected to be deposited in NDAR and will be accessible for use by all qualified investigators. In addition, blood (DNA) samples are expected to be deposited in the NIMH Repository and Genomics Resource for future research use. The Consortium project will assess the following: (1) whether eye-tracking, EEG paradigms, or a combination of the two, have potential utility as stratification biomarkers and/or as sensitive and reliable measures of change in ASD clinical trials; (2) the relationship (correlation) of validated clinical measures (including measures of social impairment) to eye tracking or EEG paradigms; and (3) the feasibility of collecting the same biomarker measures in a younger cohort.
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