Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) | PAR 18 630

Opportunity Information: Apply for PAR 18 630

The Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) funding opportunity (PAR-18-630) is a National Institutes of Health (NIH) grant program designed to support the implementation of investigator-initiated, hypothesis-driven clinical trials that genuinely need a longer timeline than a standard award. The defining feature is the extended project period: applicants must be proposing a clinical trial that requires 6 or 7 years to complete. The FOA is open to clinical trials in any phase, as long as the trial aligns with the scientific mission of one of the participating NIH Institutes and Centers (ICs). A key expectation is that the application focuses on trial implementation (not just planning), and the proposed study should be structured around a clear, testable hypothesis.

This opportunity is specifically not meant for clinical trials that can reasonably be completed in a typical project period. In other words, the extended duration is not a preference but a necessity that should be justified by the scientific and operational realities of the proposed trial, such as longer follow-up needs, complex recruitment, longitudinal outcomes, or other design elements that make a 6- or 7-year period appropriate. Because fit with an NIH IC is essential, the FOA strongly encourages prospective applicants to consult with NIH program staff before submitting, which can help confirm eligibility, ensure alignment with an institute mission, and reduce the risk of submitting an application that does not match the FOA intent.

Administratively, this is a discretionary grant mechanism under the R01 activity, categorized in the health funding area, with CFDA numbers 93.855, 93.859, and 93.866. The sponsor is the National Institutes of Health. While the source text does not list an award ceiling or expected number of awards, applicants should typically expect NIH R01 budget principles to apply, with budgets justified by the scope and needs of the trial. The original closing date shown in the source data is March 9, 2020, and the FOA record creation date is February 5, 2018, which signals that the specific listing provided is time-bound and may require checking for reissues, updates, or successor announcements if someone is looking to apply now.

Eligibility is broad and includes many common NIH applicant types: 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 (including those other than federally recognized governments); public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and other organizations. The FOA also explicitly highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, non-domestic (non-U.S.) entities/foreign organizations, Indian/Native American Tribal Governments other than federally recognized entities, and U.S. territories or possessions. This breadth reflects NIH’s intent to encourage a wide range of institutions and communities to lead complex, longer-term clinical trials when the science warrants the extended timeframe.

Overall, the program supports rigorous, investigator-driven clinical trial research that needs an unusually long runway to execute properly. The core message is straightforward: if a team has a well-justified clinical trial, grounded in a strong hypothesis, aligned with an NIH institute mission, and the work truly requires 6 or 7 years to implement and complete, this FOA is meant to provide a fitting R01 pathway. Consultation with NIH staff ahead of submission is treated as an important step rather than an optional courtesy, mainly because mission fit and the justification for the extended duration are central to whether the application matches the purpose of the announcement.

• 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, 93.859, 93.866.
• This funding opportunity was created on 2018-02-05.
• Applicants must submit their applications by 2020-03-09. (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 18 630

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