NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional) | PAR 19 155

Opportunity Information: Apply for PAR 19 155

The NHLBI Clinical Trial Pilot Studies opportunity (R34, clinical trial optional; PAR-19-155) is a discretionary NIH grant program designed to fund targeted pilot work that directly shapes the final design of a later Phase II or later clinical trial within the National Heart, Lung, and Blood Institute (NHLBI) mission. The central idea is that investigators often need a small but decisive set of data before committing to a large, expensive efficacy or effectiveness trial. This FOA supports studies that are scientifically essential and also sufficient to let a team make clear go/no-go decisions and finalize key design elements for a subsequent trial focused on heart, lung, blood, and sleep disorders. The downstream trial is expected to have a primary intent such as testing efficacy, safety, clinical management strategies, or implementation of interventions for prevention or treatment.

This R34 is meant for pilot studies that answer specific uncertainty points that could otherwise derail or weaken a larger trial. Examples of the types of questions this mechanism is meant to address include whether a proposed intervention is feasible in the intended real-world setting, what intervention parameters should be used (dose, timing, delivery approach, adherence supports), whether enough eligible participants are available and willing to enroll, whether recruitment and retention strategies will work, and whether a novel or more efficient trial design is workable. The FOA explicitly emphasizes pragmatic and efficient approaches when appropriate, including testing the feasibility of pragmatic trial designs that integrate into clinical workflows. In other words, the goal is not simply to do "a small version of the big trial," but to generate the key information needed to confidently lock down the final methods for the later Phase II-IV trial.

A critical requirement is that the application must make the case that the proposed pilot work is both necessary and sufficient to enable definitive decisions about the subsequent trial's final design. Reviewers will be looking for a tight link between the pilot study aims and the concrete design choices they will inform, such as eligibility criteria, outcome ascertainment procedures, randomization approach, site selection, recruitment plans, intervention delivery logistics, and operational feasibility. The program is positioned as different from basic planning or start-up support. It is specifically intended to produce new information that answers a scientific question (often practical or pragmatic in nature) that directly informs the later clinical trial design.

The FOA also draws a clear boundary around what is not appropriate for this mechanism. Proposals that are primarily aimed at writing a protocol or manual of operations, building general trial infrastructure, or carrying out a fully designed clinical trial are not responsive to this announcement. NHLBI notes that it has other clinical trial funding opportunities for planning, start-up, and conduct of larger trials, and it points applicants to its clinical trials optimization page for alternatives. In contrast, this R34 is meant to sit in the gap where investigators need a focused, hypothesis- or question-driven pilot effort to resolve uncertainties before moving into a definitive Phase II-IV trial.

From an administrative standpoint, the funding instrument is a grant under the health funding activity category, administered by the National Institutes of Health. The CFDA numbers associated with the opportunity include 93.233 and 93.837 through 93.840. The listed award ceiling is $225,000. The original closing date shown in the source information is 2020-11-18, and the FOA record creation date is 2019-01-08.

Eligibility is broad and includes many types of domestic organizations and governments. Eligible applicants include state, county, and 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also highlights categories such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, faith-based or community-based organizations, Hispanic-serving institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined by the NIH Grants Policy Statement. This means the applicant must be a qualifying U.S.-based organization, but the project can include certain foreign components when justified and compliant with NIH policy.

Overall, this grant opportunity is best understood as a decision-focused pilot funding mechanism: it supports limited, well-justified studies that produce the practical and scientific evidence needed to finalize a high-quality Phase II-IV clinical trial concept in the NHLBI mission space, while avoiding support for proposals that are only administrative planning or that attempt to run a full-scale trial under the guise of a pilot.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2019-01-08.
• Applicants must submit their applications by 2020-11-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $225,000.00 in funding.
• 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 19 155

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