Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) | PAR 20 139

Opportunity Information: Apply for PAR 20 139

The Investigator Initiated Extended Clinical Trial (R01 Clinical Trial Required) funding opportunity (PAR-20-139) is a National Institutes of Health (NIH) grant program designed to support investigator-initiated clinical trial implementation projects that genuinely need a longer-than-standard timeline. The defining feature of this FOA is the required extended project period: applicants must be proposing a clinical trial that needs 6 or 7 years to complete. NIH is explicitly signaling that this is not a general-purpose clinical trial R01; it is reserved for trials where the scientific and operational realities (such as long follow-up, lengthy recruitment, complex interventions, or extended outcome ascertainment) make a 6- or 7-year period appropriate and necessary.

The trials supported under this announcement can be in any clinical trial phase, but they must be hypothesis-driven and clearly aligned with the research mission of one of the participating NIH Institutes and Centers (ICs). In practical terms, the application should present a well-defined, testable clinical hypothesis, a robust study design that can credibly answer that hypothesis, and an implementation plan that fits the extended timeline. Because each NIH Institute or Center has its own mission priorities and portfolio considerations, the FOA strongly encourages applicants to consult with NIH program staff before submitting. That pre-submission contact is intended to help investigators confirm fit with an appropriate IC, clarify expectations for trial scope and timeline, and avoid submitting an application that is scientifically solid but misaligned with the participating NIH components.

This opportunity is categorized as a discretionary grant program from NIH within the health funding activity area, and it is associated with CFDA numbers 93.855 and 93.866. The funding instrument is an R01 grant, and the FOA is specifically marked "Clinical Trial Required," meaning the proposed project must meet NIH’s definition of a clinical trial and include the elements expected for clinical trial implementation (rather than early planning only). While the provided source text does not list an award ceiling or expected number of awards, applicants should typically plan budgets consistent with NIH R01 norms and the real costs of rigorous multi-year trial conduct, including enrollment, intervention delivery, data collection, participant retention, safety monitoring, and analysis.

Eligibility is broad and includes many common applicant types: state, county, city or township 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 not federally recognized; public housing authorities/Indian housing authorities; U.S. nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible applicants, including Alaska Native and Native Hawaiian 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 even non-U.S. (foreign) entities. That breadth reflects NIH’s interest in enabling strong clinical trials across diverse institutional settings and populations, including trials that may require international collaboration or recruitment.

Key administrative details from the source include the opportunity title and number (PAR-20-139), the NIH as the sponsoring agency, and an original closing date listed as 2023-01-13, with the FOA originally created on 2020-03-13. Taken together, the program’s core message is straightforward: NIH is offering an R01 pathway specifically for investigator-led clinical trials that require a 6- or 7-year implementation window, and applicants are expected to justify that extended duration, propose a hypothesis-driven trial of any phase, and coordinate early with NIH Institute/Center staff to ensure strong programmatic fit.

• 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 2020-03-13.
• Applicants must submit their applications by 2023-01-13. (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 20 139

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