Development of Clinical Outcome Assessments for Clinical Trials in Substance Use Disorders as FDA-qualified Drug Development Tools (U01 Clinical Trial Optional) | RFA DA 20 015

Opportunity Information: Apply for RFA DA 20 015

This NIH funding opportunity (RFA-DA-20-015) supports projects focused on developing better clinical outcome assessments (COAs) for use in substance use disorder (SUD) clinical trials, with the explicit aim of getting those COAs qualified by the U.S. Food and Drug Administration (FDA) as Drug Development Tools (DDTs). The central idea is to strengthen how SUD trials measure meaningful change by producing instruments that regulators can trust as rigorous, sensitive, and fit-for-purpose endpoints or outcome measures. By creating or improving COAs that can be accepted in adequate and well-controlled studies, the program is intended to reduce uncertainty in SUD trial outcomes and, over time, make it easier to evaluate and potentially gain approval for new SUD treatments.

A key feature of the announcement is its emphasis on FDA qualification. FDA qualification is not just informal acceptance; it is a formal determination, based on evidence, that a COA is a well-defined and reliable way to assess a specific concept (for example, craving severity, withdrawal impact, functional impairment, or treatment benefit as experienced by the patient) within a clearly specified context of use. That context of use matters because it defines exactly how and where the COA is intended to be used, such as in trials for a particular SUD population, stage of illness, treatment setting, or trial design. Once qualified as a DDT, the COA becomes publicly available and can be used by multiple sponsors in the qualified context without each sponsor having to rebuild the same evidentiary foundation from scratch.

The opportunity allows for a range of COA types, reflecting how outcomes can be measured in clinical research. Projects may develop patient-reported outcomes (PROs), where participants report their own symptoms or experiences; clinician-reported outcomes (ClinROs), based on clinician ratings; observer-reported outcomes (ObsROs), where someone close to the participant reports observable behaviors or impacts; or performance outcomes (PerfOs), which rely on standardized tasks or tests to measure functioning. Applications can propose entirely new COAs or focus on modifying and optimizing existing instruments, as long as the work is geared toward producing a measure that can meet FDA standards for qualification. The end goal is an FDA-qualified COA (or COAs) that regulatory authorities would consider acceptable for use in SUD clinical trials, thereby improving the field’s ability to demonstrate treatment effects and potentially accelerating the path to new therapeutic approvals.

From an award structure standpoint, this is a discretionary grant using a cooperative agreement mechanism (U01), which typically implies substantial NIH scientific or programmatic involvement during the project compared with a standard research project grant. The activity category is listed under Education and Health, and the CFDA number is 93.279. The listed award ceiling is $500,000, with expected awards not specified in the provided source. The original closing date for applications was October 23, 2019, and the opportunity was created on June 25, 2019.

Eligibility is broad and includes many common applicant types across government, academia, nonprofit, and industry. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; 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); small businesses; and additional “other” entities. The announcement also explicitly calls out additional eligible groups, including Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, tribal governments that are not federally recognized, and non-U.S. (foreign) organizations.

Overall, the opportunity is best understood as an effort to build shared, regulator-ready measurement tools for SUD trials. By investing in COAs that can be qualified and publicly disseminated as FDA DDTs, NIH is aiming to improve consistency and credibility in outcome measurement across SUD research, helping clinical trials generate clearer, more comparable evidence about whether new interventions truly benefit patients.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Development of Clinical Outcome Assessments for Clinical Trials in Substance Use Disorders as FDA-qualified Drug Development Tools (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2019-06-25.
• Applicants must submit their applications by 2019-10-23. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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 RFA DA 20 015

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