Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional) | RFA MH 24 120

Frequently Asked Questions (FAQs)

What is the "Precision Mental Health: Develop Tools to Inform Treatment Selection in Depression (UG3/UH3 Clinical Trial Optional)" opportunity?

It is a National Institutes of Health (NIH) funding opportunity (RFA-MH-24-120; CFDA 93.242) focused on speeding the development and validation of practical biomarkers or decision tools that help clinicians choose among existing depression treatments for an individual patient.

What is the main goal of this funding opportunity?

The main goal is to improve treatment selection in depression by predicting which of two or more established treatment options is most likely to work for a given person, with the end goal of improving outcomes compared to how treatment is typically chosen today.

Is this opportunity trying to create brand-new depression treatments?

No. The central idea is not to invent new treatments, but to improve how clinicians select among existing depression treatments by using biomarkers or decision tools to guide choice at the individual level.

What kinds of tools does NIH want to support under this FOA?

The FOA emphasizes practical biomarkers or decision tools that are sensitive enough to detect meaningful differences in likely treatment response for an individual patient, and that can be validated for clinical utility in guiding treatment selection.

What does "precision mental health" mean in the context of this FOA?

In this context, it refers to using measurable indicators (biomarkers) or structured decision tools to make more individualized treatment choices in depression, rather than relying primarily on clinician judgment, patient preference, trial-and-error, or standard guidelines.

What funding mechanism is being used?

The opportunity uses a phased cooperative agreement structure: UG3/UH3 (and the description references similar phased mechanisms like R61/R33). Cooperative agreements generally involve substantial NIH programmatic involvement during the project.

What does "phased" mean for UG3/UH3 projects?

Projects are expected to move through a structured development pipeline with clear milestones. Phase 1 focuses on de-risking the approach, and Phase 2 focuses on larger-scale prospective testing/validation.

How long can Phase 1 (UG3) last?

Phase 1 can last up to two years.

What is Phase 1 supposed to accomplish?

Phase 1 is meant to "de-risk" the proposed biomarker or decision tool by using efficient early-stage approaches to determine whether there is a strong enough predictive signal to justify a larger, prospective study.

What types of Phase 1 activities are encouraged?

Examples provided include retrospective secondary analyses of data from completed depression clinical trials and/or fast, nimble pilot studies designed to quickly determine whether the signal is strong enough to support a larger prospective trial.

What are "go/no-go" decision points in Phase 1?

They are objective milestones tied to decisions about whether the project should advance to Phase 2. The FOA describes Phase 1 as explicitly tied to quantitative, objective criteria rather than only generating interesting correlations.

What are examples of quantitative criteria that can be used for Phase 1 go/no-go decisions?

The FOA provides examples such as futility analyses, receiver operating characteristic (ROC) curves, and/or effect size benchmarks.

Why does the FOA emphasize de-risking and quantitative evidence in Phase 1?

Because Phase 2 is larger and more resource-intensive, Phase 1 is intended to provide quantitative evidence that the biomarker or tool has plausible clinical utility for guiding treatment selection before investing in large-scale prospective testing.

How long can Phase 2 (UH3) last?

Phase 2 can last up to five years.

What is the focus of Phase 2?

Phase 2 focuses on prospective, large-scale testing of the biomarker or decision tool, including evaluation in biomarker/tool-stratified clinical trials where appropriate.

How is the biomarker or tool tested in Phase 2?

The FOA describes a real-world decision context in which participants are assigned treatment either using a biomarker/tool-guided strategy (the test approach) or using standard-of-care decision-making (the comparison approach).

What is the comparison or "control" condition described for Phase 2 testing?

The comparison is described as clinician/patient treatment assignment, reflecting what typically happens in practice (usual decision-making).

What is the "test" condition described for Phase 2 testing?

The test condition is treatment assignment guided by the new biomarker or decision tool.

What does success look like for a Phase 2 project?

The key performance bar is practical and patient-centered: the tool should enable a treatment-selection strategy that outperforms usual decision-making, not merely show statistical associations.

Are clinical trials required under this FOA?

The clinical trial component is described as optional under UG3/UH3. However, the overall narrative for Phase 2 clearly prioritizes prospective validation in a clinical-trial framework when appropriate.

What does "Clinical Trial Optional" imply here?

It means the FOA is structured to accommodate projects that may or may not include a clinical trial, while still emphasizing prospective validation and real-world testing of decision utility when appropriate.

Who is eligible to apply?

Eligibility is broad and intentionally inclusive. Eligible applicants include many U.S. governmental entities, higher education institutions, nonprofit organizations, for-profit organizations (other than small businesses), and small businesses, among others listed in the announcement.

Are state and local governments eligible?

Yes. The FOA includes U.S. governmental entities such as state governments, county governments, city or township governments, special district governments, and independent school districts.

Are colleges and universities eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.

Are nonprofits eligible to apply?

Yes. The FOA includes nonprofit organizations with 501(c)(3) status and nonprofit organizations without 501(c)(3) status.

Are for-profit organizations eligible?

Yes. For-profit organizations are eligible, with the note that the listing distinguishes for-profit organizations (other than small businesses) and also includes small businesses as eligible applicants.

Are small businesses eligible to apply?

Yes, small businesses are explicitly included among eligible applicants.

Are Native American tribal governments and tribal organizations eligible?

Yes. The FOA explicitly welcomes applications from Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments).

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are listed among eligible applicant types.

Does the FOA encourage applications from specific institution types such as HBCUs and HSIs?

Yes. The announcement highlights eligibility for multiple institution types, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are mentioned among the eligible applicant categories highlighted in the listing.

Are U.S. territories or possessions eligible?

Yes. The listing references U.S. territories or possessions among the highlighted eligible applicant types.

Are foreign (non-U.S.) organizations eligible to apply?

Yes. The listing notes that non-U.S. entities (foreign organizations) are included among the eligible applicant types in the provided excerpt.

What type of funding is this categorized as?

It is categorized as discretionary funding.

What is the funding instrument for this opportunity?

The funding instrument is a cooperative agreement, which indicates substantial NIH programmatic engagement during the project.

What is the closing date listed in the provided information?

The original closing date listed is April 3, 2024.

Does the provided excerpt specify the award ceiling or the expected number of awards?

No. The provided excerpt does not specify an award ceiling or the expected number of awards.

What problem in depression care is this FOA trying to address?

It targets the limitations of common treatment selection approaches (clinician judgment, patient preference, trial-and-error, or standard guidelines) by supporting tools that can better predict which established treatment is most likely to work for an individual patient.

What is the overall program logic from start to finish?

The FOA supports a stepwise process: Phase 1 provides quantitative evidence that a biomarker or tool has a strong enough predictive signal and plausible clinical utility to justify further investment, and Phase 2 prospectively tests whether using the tool to guide treatment selection improves patient outcomes compared to standard care decision-making.