Targeting Biomarkers and the FDA’s Biomarker Qualification Framework

This Viewpoint argues for adding a new category, targeting biomarkers, to the US Food and Drug Administration’s biomarker qualification framework.

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Publication Details

Journal
JAMA Psychiatry
Published
2026-04-15
DOI
https://doi.org/10.1001/jamapsychiatry.2026.0590
Primary Topic
Statistical Methods in Clinical Trials
Type
article
Field-Weighted Citation Impact
0.00
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article

Targeting Biomarkers and the FDA’s Biomarker Qualification Framework

Hamed Ekhtiari, Arshiya Sangchooli, Michael D. Fox, Alex Fornito
JAMA Psychiatry
Statistical Methods in Clinical Trials
article

Targeting Biomarkers and the FDA’s Biomarker Qualification Framework

Hamed Ekhtiari, Arshiya Sangchooli, Michael D. Fox, Alex Fornito
article en

Abstract

This Viewpoint argues for adding a new category, targeting biomarkers, to the US Food and Drug Administration’s biomarker qualification framework.

JAMA Psychiatry
Circuit Therapeutics (United States) (US), Monash University (AU), The University of Texas Southwestern Medical Center (US)
Zero hunger
Openalex Percentile: Top 17%
Statistical Methods in Clinical Trials
DOISourceOpenAlex
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