National Institutes of Health

Description

The purpose of this phased Notice of Funding Opportunity (NOFO) is to create a pipeline to accelerate the development and early validation of predictive tools and/or biomarkers to inform individual-level treatment selection among two or more existing therapeutics for depression. This phased inter-agency program will be milestone-based and provide support from multi-disciplinary teams to address scientific, technical, clinical, regulatory, and commercialization requirements. In the first phase (UG3), investigators are expected to identify potential tools and/or biomarker(s) that can predict whether a patient will differentially respond to one well-established depression treatment versus another. This could be accomplished using secondary analysis of data from completed clinical trials or using real-world clinical data, or by conducting small, efficient pilot feasibility studies to assess promising new tools or biomarkers to predict individual treatment response to a specific therapeutic for depression. In the second phase (UH3), investigators will conduct independent, prospective clinical trials to initially validate the utility of the tool/biomarker for predicting differential response to established treatments for depression. The overall goal of this NOFO is to support the testing of various tools/biomarkers as predictors of response to well-established depression treatments and halt the development of those tools that do not meet sufficient performance characteristics to justify further testing. Ultimately, tools that are successful in early-stage studies could be further evaluated for future use in decision-making in clinical practice settings.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

NIH Grants Information<br/>grantsinfo@nih.gov
grantsinfo@nih.gov