Opportunity Information: Apply for PAR 23 084
The National Institutes of Health (NIH) is soliciting applications under the funding opportunity titled "Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required)" (PAR-23-084). This announcement supports investigator-initiated clinical trial implementation projects that genuinely need a longer timeline than a typical R01, specifically allowing an extended project period of 6 or 7 years. The intent is to fund the conduct of a full clinical trial, not just planning activities, and the trial may be in any phase as long as it is clearly hypothesis-driven and fits within the research mission of the participating NIH Institute or Center (IC).
A central feature of this FOA is the emphasis on the need for an extended duration. NIH is making it clear that this mechanism is meant for trials where the science or logistics require 6 to 7 years to complete, such as longer follow-up to observe outcomes, extended recruitment timelines for hard-to-reach populations, complex interventions that require long implementation periods, or endpoints that naturally occur over longer time horizons. Applications proposing trials that could reasonably be completed within a standard project period are not the target of this announcement, and applicants are expected to justify why the extended period is necessary for the proposed trial.
Because this is an R01 clinical trial required announcement, the application must involve the implementation of a clinical trial and should include the operational and scientific components expected for a rigorous NIH-funded trial. That typically means a clear primary hypothesis and endpoints, a well-defined study design, a feasible recruitment and retention plan, appropriate statistical and power considerations, data management and quality control procedures, and protections for human subjects appropriate to the risk level and population being studied. The trial can be conducted in any clinical domain aligned with the participating ICs, but alignment with an IC mission is essential for responsiveness and funding consideration.
NIH strongly encourages applicants to consult with NIH program staff at the relevant Institute or Center before submitting. This pre-submission contact is important in practice because it helps confirm whether the proposed trial is a good fit for the participating IC, whether the extended timeline is justified, and whether the application aligns with the expectations specific to this FOA. Early communication can also help applicants avoid common pitfalls such as proposing the wrong activity (for example, planning-only work), underestimating the operational complexity of a multi-year trial, or missing Institute-specific priorities.
Eligibility is broad and includes many types of organizations. Eligible applicants include state, county, city or 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; nonprofit organizations (both with and without 501(c)(3) status, excluding institutions of higher education where applicable); for-profit organizations (other than small businesses); small businesses; and other organizations. The announcement also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. entities (foreign organizations). This breadth is meant to enable a wide range of capable research and community partners to lead or participate in long-duration clinical trials.
From an administrative standpoint, this opportunity is a discretionary grant mechanism offered by NIH under the health research funding category. The associated CFDA numbers listed are 93.855 and 93.866. The original closing date shown for this opportunity is January 13, 2026. While the notice provides fields such as award ceiling and expected awards, those values are not specified in the provided source text, so applicants should rely on the full FOA and any Institute-specific guidance for budget expectations and likely award levels.
In practical terms, this FOA is best understood as an NIH pathway for investigators who have a mature, implement-ready clinical trial concept that requires a long runway to execute correctly. It is designed for substantial, hypothesis-driven trials that need 6 to 7 years to recruit, deliver an intervention, and/or observe outcomes, and it expects applicants to engage NIH staff early to confirm fit and requirements before submission.Apply for PAR 23 084
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigator Initiated Extended Clinical Trial (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): 93.855, 93.866.
- This funding opportunity was created on 2023-01-12.
- Applicants must submit their applications by 2026-01-13. (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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Frequently Asked Questions (FAQs)
What is this funding opportunity?
This is a National Institutes of Health (NIH) funding opportunity titled "Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required)" (PAR-23-084). It supports investigator-initiated projects to implement and conduct a full clinical trial under the R01 mechanism, with an extended project period.
What type of grant mechanism is being used?
The announcement uses the NIH R01 mechanism and is specifically designated as "Clinical Trial Required," meaning the application must include the implementation of a clinical trial (not just related research that does not meet the definition of a clinical trial).
What is the main purpose of this FOA?
The central purpose is to fund the conduct of a full, hypothesis-driven clinical trial that genuinely needs more time than a typical R01 project period. NIH is targeting trials where the science or logistics require a 6- or 7-year timeline to complete.
How long can the project period be under this opportunity?
This FOA allows an extended project period of 6 or 7 years.
What makes a project a good fit for the "extended" timeline?
Projects are a good fit when the clinical trial cannot reasonably be completed within a standard project period and the application can justify why 6 to 7 years is necessary. Examples mentioned include longer follow-up to observe outcomes, extended recruitment for hard-to-reach populations, complex interventions requiring long implementation periods, or endpoints that naturally occur over longer time horizons.
Can I apply if my clinical trial could be completed in a standard R01 timeframe?
This FOA is not intended for trials that could reasonably be completed within a standard project period. Applicants are expected to clearly justify the need for the 6- to 7-year duration.
Does this FOA support planning-only activities?
No. The intent is to fund the conduct and implementation of a full clinical trial, not just planning activities. Applications focused on planning-only work are highlighted as a common mismatch to avoid.
What phases of clinical trials are allowed?
The trial may be in any phase, as long as it is clearly hypothesis-driven and fits within the research mission of the participating NIH Institute or Center (IC).
Does the clinical trial need to be hypothesis-driven?
Yes. The FOA emphasizes that the trial should be clearly hypothesis-driven, with a primary hypothesis and endpoints appropriate for a rigorous NIH-funded clinical trial.
What kinds of clinical domains or topics can be proposed?
The trial can be in any clinical domain, as long as it aligns with the mission of a participating NIH Institute or Center (IC). Mission alignment is essential for responsiveness and funding consideration.
Why is alignment with an NIH Institute or Center (IC) mission important?
Alignment with a participating IC mission is described as essential for responsiveness and for funding consideration. In practical terms, applicants need the proposed trial to fit the priorities and scope of the relevant IC.
Is contacting NIH program staff before applying required or recommended?
NIH strongly encourages pre-submission consultation with program staff at the relevant Institute or Center. This is recommended to confirm fit with the participating IC, ensure the extended timeline is justified, and make sure the application matches the expectations of this FOA.
What can I gain by contacting NIH program staff early?
Early consultation can help confirm whether the proposed clinical trial is a good fit for the participating IC, whether the 6- to 7-year timeline is appropriate, and whether the application aligns with FOA expectations. It can also help avoid common pitfalls such as proposing planning-only work, underestimating operational complexity for a multi-year trial, or missing Institute-specific priorities.
What are the key application components NIH expects for a rigorous clinical trial under this FOA?
NIH expects the operational and scientific components typical for a rigorous trial, including: a clear primary hypothesis and endpoints, a well-defined study design, a feasible recruitment and retention plan, appropriate statistical and power considerations, data management and quality control procedures, and human subjects protections appropriate to the risk level and study population.
Does the FOA specify requirements related to recruitment and retention?
Yes. The description highlights the need for a feasible recruitment and retention plan as part of the expected clinical trial implementation package.
Does the FOA mention statistical or power expectations?
Yes. It calls out appropriate statistical and power considerations as part of what a complete clinical trial application should include.
Does the FOA mention data management and quality control?
Yes. Data management and quality control procedures are explicitly noted among the expected components for a rigorous NIH-funded trial.
What does "Clinical Trial Required" mean in practice for applicants?
Based on the information provided, it means the application must involve the implementation and conduct of a clinical trial, including the operational elements expected for an NIH-funded trial, rather than proposing only planning activities or non-trial research.
Who is eligible to apply?
Eligibility is broad and includes many organization types, including: state, county, city or 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; nonprofit organizations (with or without 501(c)(3) status, excluding institutions of higher education where applicable); for-profit organizations (other than small businesses); small businesses; and other organizations.
Are minority-serving institutions and community-based organizations eligible?
Yes. The announcement explicitly highlights additional eligible categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities, and faith-based or community-based organizations.
Are U.S. territories, regional organizations, or federal agencies eligible?
Yes. The FOA highlights eligible federal agencies, U.S. territories or possessions, and regional organizations among the eligible applicant categories.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The announcement explicitly includes non-U.S. entities (foreign organizations) among eligible applicants.
What is the funding category and administering agency?
This is a discretionary grant mechanism administered by NIH, under the health research funding category.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.855 and 93.866.
What is the closing date shown for this opportunity?
The original closing date shown is January 13, 2026.
Does the provided information state the award ceiling or the expected number of awards?
No. The provided source text notes that fields such as award ceiling and expected awards are not specified, and applicants should rely on the full FOA and any Institute-specific guidance for budget expectations and likely award levels.
What kinds of projects does NIH seem to be encouraging through this FOA?
This FOA is positioned as a pathway for investigators with a mature, implement-ready clinical trial concept that needs a long runway (6 to 7 years) to recruit participants, deliver an intervention, and/or observe outcomes. It is aimed at substantial, hypothesis-driven trials rather than exploratory planning work.
What is a common pitfall this FOA is trying to prevent?
The description highlights several common pitfalls that early NIH staff communication can help avoid, including proposing the wrong activity (such as planning-only work), underestimating the operational complexity of a multi-year trial, or missing Institute-specific priorities.
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