Investigator Initiated Extended Clinical Trial (R01) | PAR 17 056

Opportunity Information: Apply for PAR 17 056

The Investigator Initiated Extended Clinical Trial (R01) funding opportunity (PAR-17-056) is a National Institutes of Health (NIH) grant announcement designed to support the implementation of investigator-initiated clinical trials that genuinely need a longer-than-usual timeline. The central feature is the extended project period: applications are intended for clinical trials that require 6 or 7 years to complete, reflecting situations where recruitment, follow-up, outcome accrual, or operational complexity makes a standard R01 timeframe insufficient. The FOA is specifically focused on running the clinical trial itself (implementation), not just early planning activities, and it emphasizes that the study must be hypothesis-driven, meaning it should be built around clear, testable scientific questions rather than being primarily exploratory or descriptive.

This opportunity is broad in terms of the kinds of trials it will consider. Trials can be in any phase, as long as they align with the research mission of one of the participating NIH Institutes and Centers (ICs). In practice, that means applicants need to ensure their topic, population, intervention, outcomes, and overall scientific purpose fit squarely within the priorities and statutory mission of an NIH IC that participates in this announcement. A key expectation is that prospective applicants communicate with NIH program staff before submitting an application. That pre-submission consultation is strongly encouraged because it helps confirm IC fit, clarify whether the proposed timeline and scope truly warrant a 6- or 7-year project period, and avoid developing an application that the NIH views as mismatched to the intent of the FOA.

The FOA also draws a clear boundary around what it is not meant to fund: it is not intended for clinical trials that do not require an extended 6- or 7-year project period. In other words, if a trial can reasonably be completed within a typical project duration, this announcement is not the appropriate mechanism. The emphasis is on justification of the extended timeline as a scientific and operational necessity, such as long-term follow-up to observe clinically meaningful outcomes, multi-site recruitment challenges, extended intervention delivery, or the need to measure endpoints that naturally take years to develop.

From an eligibility standpoint, the announcement is inclusive and allows applications from a wide range of organizations. Eligible applicants include various levels of government (state, county, city/township, and special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, and both federally recognized tribal governments and other tribal organizations. It also includes nonprofits with or without 501(c)(3) status, public housing authorities/Indian housing authorities, for-profit organizations (other than small businesses), and small businesses, as well as an "others" category that captures additional eligible entities. The FOA explicitly highlights additional eligible groups 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-U.S. (foreign) organizations.

Administratively, this is an NIH discretionary grant using the R01 funding instrument, within the Health funding activity category. The CFDA numbers associated with this opportunity are 93.855, 93.856, 93.859, and 93.866. The source information indicates the opportunity was created on 2016-11-17 and listed an original closing date of 2018-01-23. No award ceiling or expected number of awards is specified in the provided data, which is common for NIH FOAs where budgets and award counts can vary based on scientific merit, available funds, and IC priorities.

In plain terms, this FOA is meant for investigators who already have a well-developed, rigorous clinical trial ready to run, where the science requires a longer arc than usual. The best-fit applications are those that can convincingly explain why 6 to 7 years is essential to answer an important clinical question, show strong alignment with an NIH Institute or Center mission, and demonstrate readiness to execute a complex trial over an extended period with appropriate oversight, staffing, and operational planning.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Investigator Initiated Extended Clinical Trial (R01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855, 93.856, 93.859, 93.866.
• This funding opportunity was created on 2016-11-17.
• Applicants must submit their applications by 2018-01-23. (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 17 056

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