Opportunity Information: Apply for PAR 23 057
The NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required), Funding Opportunity Number PAR-23-057, is a National Institutes of Health discretionary grant opportunity that supports the actual conduct and execution of investigator-initiated, multi-site interventional clinical trials. It is designed for trials in any phase, as long as the work is interventional, hypothesis-driven, and clearly structured around defined milestones that allow progress to be tracked and managed across participating sites. The scientific focus of the proposed trial must align with the National Institute on Aging (NIA) research mission, meaning applicants should ensure their clinical question, target population, outcomes, and overall rationale are tightly connected to aging-related research priorities described by NIA.
This FOA is specifically aimed at the implementation stage of a multi-site study, which typically means the application should be ready to move into trial operations rather than early concept development. In practical terms, that generally implies applicants are expected to present a well-justified research plan, a realistic and well-governed multi-site structure, and an operational approach that addresses core clinical trial requirements such as recruitment and retention strategies, protocol adherence across sites, data collection and management, safety monitoring, and performance benchmarks. The emphasis on being milestone-defined signals that the funding agency expects applicants to lay out measurable deliverables (for example, site activation timelines, enrollment targets, follow-up completion rates, and data quality metrics) and to manage the project using those checkpoints.
Eligibility is broad and includes many types of U.S.-based organizations as well as certain non-U.S. entities. Eligible applicants include state, county, city, township, and 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 that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits both with and without 501(c)(3) status (excluding institutions of higher education when relevant); for-profit organizations other than small businesses; small businesses; and other organizations that meet NIH eligibility rules. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities/foreign organizations, indicating a strong openness to a wide range of institutional settings and community-connected research infrastructure.
Administratively, the opportunity is offered by the National Institutes of Health under the Health funding activity category and is associated with CFDA number 93.866. The funding instrument is a grant, and the title specifies that it is an R01 mechanism with a clinical trial required component, meaning the application must propose a clinical trial that meets NIH’s definition and the project will be reviewed and managed accordingly. The original closing date listed is January 7, 2026. The provided source information does not specify an award ceiling or the expected number of awards, so applicants would typically need to consult the full FOA text and NIH guidance for any budget-related expectations, allowable costs, and submission details.Apply for PAR 23 057
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.866.
- This funding opportunity was created on 2022-11-30.
- Applicants must submit their applications by 2026-01-07. (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.
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FAQs: NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required) - PAR-23-057
What is the PAR-23-057 funding opportunity?
PAR-23-057 is the NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required), a National Institutes of Health (NIH) discretionary grant opportunity. It supports the actual conduct and execution of investigator-initiated, multi-site interventional clinical trials.
Which NIH Institute is sponsoring this opportunity?
The opportunity is tied to the National Institute on Aging (NIA). The trial's scientific focus must align with the NIA research mission and aging-related research priorities.
What type of projects does this FOA support?
This FOA supports multi-site interventional clinical trials that are hypothesis-driven and structured around defined milestones. It is focused on implementation, meaning it supports trial operations and execution rather than early-stage concept development.
Does my application have to include a clinical trial?
Yes. The mechanism is listed as "R01 Clinical Trial Required," which means the application must propose a clinical trial that meets NIH's definition and will be reviewed and managed as a clinical trial.
Are single-site clinical trials eligible under this FOA?
The opportunity is specifically described as supporting multi-site interventional clinical trials. Based on the information provided, it is designed for trials involving multiple participating sites rather than single-site studies.
What phases of clinical trials are allowed?
Trials in any phase may be proposed, as long as the work is interventional, hypothesis-driven, and organized around clearly defined milestones that allow progress to be tracked across sites.
What does "implementation stage" mean for this grant?
It means the application should be ready to move into trial operations. In practical terms, applicants are expected to present a well-justified research plan, a realistic and well-governed multi-site structure, and an operational approach that covers core clinical trial requirements.
What are examples of milestones that NIA expects to see?
The FOA emphasizes measurable deliverables that can be tracked and managed across sites. Examples mentioned include site activation timelines, enrollment targets, follow-up completion rates, and data quality metrics.
What operational elements should a strong application address?
Based on the description provided, applicants should address clinical trial operations such as recruitment and retention strategies, protocol adherence across sites, data collection and management, safety monitoring, and performance benchmarks.
How important is alignment with the NIA mission?
Alignment is essential. The scientific focus of the proposed trial must match the NIA research mission, and applicants should ensure the clinical question, target population, outcomes, and rationale are tightly connected to aging-related research priorities.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include many U.S.-based organizations and certain non-U.S. entities, consistent with NIH eligibility rules.
Are state and local government entities eligible?
Yes. Eligible applicants include state, county, city, township, and special district governments.
Are schools and universities eligible?
Yes. Eligible applicants include independent school districts, public and state-controlled institutions of higher education, and private institutions of higher education.
Are tribal governments and tribal organizations eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments, as well as tribal organizations that are not federally recognized.
Are nonprofits eligible (including those without 501(c)(3) status)?
Yes. The eligibility list includes nonprofits with and without 501(c)(3) status (with the noted exclusion "excluding institutions of higher education when relevant").
Are for-profit organizations eligible?
Yes. Eligible applicants include for-profit organizations other than small businesses, and small businesses are also listed as eligible.
Are housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are included among eligible applicant types.
Are faith-based or community-based organizations eligible?
Yes. The FOA highlights faith-based or community-based organizations among additional eligible applicant categories.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are highlighted as additional eligible applicant categories.
Are non-U.S. (foreign) organizations eligible?
Yes. The FOA indicates that non-domestic (non-U.S.) entities/foreign organizations are included among eligible applicant categories, subject to NIH eligibility rules.
What is the funding instrument and mechanism?
The funding instrument is a grant, and the mechanism is an R01 with a clinical trial required component.
What is the funding activity category?
The funding activity category is Health.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.866.
When is the closing date for this opportunity?
The original closing date listed is January 7, 2026.
Does the provided information include an award ceiling or the expected number of awards?
No. The provided source information does not specify an award ceiling or the expected number of awards.
Where should applicants look for budget limits, allowable costs, and submission details?
Because the provided information does not include budget-related expectations or submission specifics, applicants would typically need to consult the full FOA text and NIH guidance for allowable costs, budget expectations, and submission details.
What is the overall goal of emphasizing milestone-defined, multi-site management?
The milestone-defined approach signals that the funding agency expects measurable checkpoints and active project management across participating sites, allowing progress to be tracked and managed during trial implementation.
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