NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional) | PAR 24 049

Opportunity Information: Apply for PAR 24 049

The NHLBI Clinical Trial Pilot Studies funding opportunity (PAR-24-049) uses the NIH R34 mechanism to support focused pilot work that directly enables the design and planning of a later Phase II, III, or IV clinical trial within the mission of the National Heart, Lung, and Blood Institute. The core idea is that the proposed R34 project should generate information that is both necessary and sufficient for the next trial to be finalized. In other words, applicants are expected to clearly describe the future, larger clinical trial they want to run and then justify why the specific pilot questions in the R34 must be answered to responsibly and efficiently launch that subsequent trial. The R34 is not meant to be a generic feasibility study with open-ended next steps; it is meant to produce concrete results that remove key uncertainties so the larger trial can move forward without needing additional preliminary studies.

The planned future clinical trial, which the R34 is intended to inform, must be a Phase II to Phase IV effort that primarily focuses on testing one or more interventions related to prevention and/or treatment of heart, lung, blood, and sleep disorders. The trial focus can include efficacy and safety questions, clinical management strategies, or implementation approaches, as long as it aligns with NHLBI priorities and is positioned as a later-stage clinical trial (Phase II-IV). A key distinction in this announcement is that the R34 is not simply for administrative start-up activities or routine trial preparation tasks. Instead, it supports work that yields new scientific or operational knowledge that materially shapes the final design of the later trial. The NOFO explicitly notes that the questions addressed by the R34 may be pragmatic in nature, meaning they can involve real-world operational barriers and decision points that determine whether a Phase II-IV trial can be conducted successfully and how it should be structured.

Applications are expected to make a clear case that the pilot study is scientifically necessary to plan the subsequent trial and that the outputs will be sufficient to inform the final trial design. That typically means the R34 should answer high-impact design questions that would otherwise introduce major risk to the later trial, such as uncertainties affecting recruitment and retention, intervention delivery and fidelity, site readiness, outcome ascertainment and measurement logistics, adherence strategies, data collection workflows, safety monitoring approaches, or other practical elements that directly affect trial feasibility and interpretability. The emphasis is on producing actionable evidence that will concretely guide the protocol and operational plan for the Phase II-IV trial, rather than collecting preliminary data that still leaves the core design unresolved.

It is also important to note the funding pathway: receiving an R34 award under this NOFO does not automatically lead to funding for the later Phase II-IV clinical trial. Even if the pilot produces strong results, support for the future clinical trial will require a separate, new application, and that later application will be evaluated on its own merits. The R34 should therefore be written as a self-contained project with deliverables that stand on their own while clearly serving the purpose of enabling a well-justified, well-designed later-stage clinical trial.

Eligibility is broad and includes many types of domestic organizations and government entities. 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; nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education as noted in the eligibility list); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible applicant types 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and Indian/Native American tribal governments (including those other than federally recognized, as specified). Foreign organizations (non-domestic entities) are not eligible to apply as applicant organizations, but non-domestic components of U.S. organizations are eligible, and foreign components are allowed under the NIH Grants Policy Statement definitions.

Administratively, this is a discretionary grant opportunity under the National Institutes of Health, with health-related activity categories and CFDA numbers listed as 93.233, 93.837, 93.838, 93.839, and 93.840. The opportunity was created on 2023-11-03, and the original closing date shown is 2027-01-07. The listing does not provide an award ceiling or expected number of awards in the provided source text, so applicants should rely on the full NOFO and NIH guidance for budget expectations, project period limits, and application due dates tied to NIH receipt cycles.

Taken together, the main takeaway is that this R34 is designed for applicants who already have a clear concept for a Phase II-IV clinical trial in heart, lung, blood, or sleep health, but who need a tightly scoped, high-yield pilot project to answer specific scientific or operational questions that would otherwise prevent a well-designed, fully justified trial. The strongest applications will connect every pilot aim to an explicit decision point in the later trial, showing exactly how the R34 results will finalize the protocol, reduce risk, and enable a credible Phase II-IV clinical trial application.

• 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 2023-11-03.
• Applicants must submit their applications by 2027-01-07.
• 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.

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