Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) | PAR 23 084

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.

• 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.

Apply for PAR 23 084

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