Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional) | PAR 18 268

Opportunity Information: Apply for PAR 18 268

This NIH funding opportunity (PAR-18-268) supports a cooperative agreement project designed to close a common problem in mental health treatment development: promising findings in animal or other preclinical work often fail to translate cleanly to humans. The program focuses on neurophysiological measures (for example, brain or nervous system signals that can be quantified in a consistent way) and aims to turn the most informative of these measures into practical "assays" that can be used during treatment development. In plain terms, the initiative is trying to identify and refine measurable neurophysiological readouts that can help researchers evaluate whether a potential drug or device therapy is engaging the intended biological target and producing the expected functional effect, in ways that are meaningfully comparable across species and relevant to mental disorders.

A central feature of the FOA is its emphasis on work conducted in both healthy humans and at least one other species that fits into the therapeutic development pipeline. Applicants are expected to optimize and evaluate measures of neurophysiological processes that are disrupted within a specific mental disorder or shared across multiple disorders. The program supports early, proof-of-concept research to determine whether a given measure has the properties needed for eventual use as a preclinical assay, such as sensitivity to manipulation, reliability, and potential relevance to treatment mechanisms. The goal is not only to identify measures that align between preclinical models and humans, but also to clearly document where they do not align, so the field has solid evidence for when animal-to-human extrapolation is risky or unsupported.

The practical outcome NIH is aiming for is a more efficient, less guesswork-driven treatment development pathway for mental disorders. By systematically comparing how specific neurophysiological measures behave in animals and humans, awardees will help define which readouts can serve as coherent bridges between preclinical screening and clinical evaluation. When measures show strong cross-species coherence, they can potentially be used to improve target validation, screen candidates more effectively, and make earlier go/no-go decisions. When measures diverge across species, the data still have high value because they establish clear limits on interpretation and reduce the temptation to overstate translational significance. Over time, this is intended to speed the arrival of more effective therapies by improving the quality of evidence used to advance (or stop) candidate drugs and devices.

Mechanistically, the opportunity uses a UG3/UH3 phased cooperative agreement structure and is labeled "Clinical Trial Optional." That structure typically indicates an initial, milestone-driven planning and feasibility phase (UG3) followed by an expanded implementation phase (UH3) if predefined goals are met, with substantial involvement from NIH program staff consistent with a cooperative agreement. The "clinical trial optional" label means applicants may propose studies that meet the NIH definition of a clinical trial, but they are not required to do so; projects can be either clinical-trial or non-clinical-trial depending on the approach and aims.

Eligibility is broad and includes many types of institutions and organizations. Eligible applicants span state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, regional organizations, non-U.S. (foreign) entities, and U.S. territories or possessions.

Administratively, the opportunity is listed as a discretionary funding program under the NIH, within the health funding activity category, with CFDA number 93.242, and uses the cooperative agreement funding instrument. The source data provided show an original closing date of 2018-10-24 and a creation date of 2017-11-21, indicating this particular posting is from a prior cycle; anyone considering applying would need to check whether the FOA has been reissued, updated, or replaced by a newer announcement.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Novel Assays to Address Translational Gaps in Treatment Development (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2017-11-21.
• Applicants must submit their applications by 2018-10-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: 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 tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 18 268

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