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Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional)
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).
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).
Agency: Department of Health and Human Services
Office: National Institutes of Health
Estimated Funding: $200,000
Office: National Institutes of Health
Estimated Funding: $200,000
Who's Eligible
Obtain Full Opportunity Text:
https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-24-120.html
Additional Information of Eligibility:
Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U. S. Territory or Possession.
Full Opportunity Web Address:
http://grants.nih.gov/grants/guide/rfa-files/RFA-MH-24-120.html
Contact:
Agency Email Description:
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Agency Email:
Date Posted:
2023-06-02
Application Due Date:
Archive Date:
2024-11-23
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