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Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional)
HHS-NIH11
Status:
Active
June 2, 2023
Posted:
Deadline:
October 18, 2024
Funding
Program:
Award Floor:
Ceiling:
Match Required?
No
Eligibility
All
States:
Entity Types:
State governments, County governments, City or township governments, Special district governments, Independent school districts, Public & State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities, Native American tribal organizations, Nonprofits (with 501(c)(3) status), Nonprofits (without 501(c)(3) status)
The goal of this phased FOA (either R33/R61 or UG3/UH3) is to accelerate the development of sensitive biomarkers/tools to predict individual treatment-response between two or more existing treatments for depression. In phase 1 (up to 2 years) preliminary studies (e.g., retrospective secondary analyses of data from completed clinical trials and/or in nimble, fast-fail pilot studies) will de-risk the test technology demonstrating that there is enough signal for clinical utility (futility analyses, ROC curves, and/or effect size will be evaluated as go/no-go criteria). Phase 2 (up to 5 years) innovators will prospectively test the efficacy of the biomarker/tool in large-scale biomarker/tool-stratified clinical trials with the goal of beating standard-of-care decision-making (i.e., clinician/patient treatment assignment will be the CTRL group vs the test).