NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional) | PAR 25 032

Opportunity Information: Apply for PAR 25 032

The NHLBI Clinical Trial Pilot Studies opportunity (R34 Clinical Trial Optional), Funding Opportunity Number PAR-25-032, is a National Institutes of Health grant program designed to fund focused pilot work that directly strengthens the planning of a later Phase II, III, or IV clinical trial within the NHLBI mission areas. The core idea is that the R34 project is not meant to simply help a team get organized or complete routine trial start-up tasks; it is meant to generate new, decision-ready evidence that is both necessary and sufficient to finalize the design of a future efficacy, safety, clinical management, or implementation trial aimed at preventing or treating heart, lung, blood, and sleep disorders. Applications are expected to clearly describe the clinical trial the investigators ultimately want to run and then make a compelling case that the proposed R34 work is scientifically required to plan that trial properly.

This NOFO emphasizes that the R34 study should answer specific scientific and/or operational questions that could otherwise derail, weaken, or unnecessarily complicate the later Phase II-IV trial. In practical terms, that might include questions about feasibility of recruitment or retention in a particular population, the practicality of delivering an intervention in real-world settings, the acceptability of procedures to participants or clinical sites, refinement of endpoints or outcome assessments, validation of data collection workflows, testing implementation strategies, or other pragmatic issues that influence whether a larger trial is likely to succeed and how it should be structured. The expectation is that the pilot results will be adequate to support final decisions about trial design without needing a second round of preliminary studies.

A key point in the announcement is how this R34 differs from NHLBI clinical trial optimization or start-up mechanisms. Rather than functioning as a preparation phase that funds administrative planning or standard start-up activities, this R34 is positioned as a mechanism to produce new information that resolves a targeted uncertainty. The project should therefore be framed around well-defined uncertainties and clear go/no-go style outputs that directly translate into final trial decisions (for example, confirming the best recruitment approach, selecting the most workable intervention delivery model, or determining whether a proposed endpoint is measurable and meaningful under real clinical conditions).

The planned future trial that the R34 is informing must be a Phase II-IV clinical trial primarily intended to test one or more interventions for efficacy, safety, clinical management, or implementation in NHLBI-relevant conditions. Importantly, receiving an R34 award does not automatically lead to funding for the subsequent full clinical trial. Even if the pilot work is successful, the future Phase II-IV trial will require a separate, new application and will be reviewed and considered on its own merits.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities, such as 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; Native American tribal governments (federally recognized) and tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The NOFO also explicitly highlights additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Foreign eligibility is limited. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as applicant organizations. However, non-domestic components of U.S. organizations may participate, and foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning parts of the work can be conducted internationally under the umbrella of a U.S. applicant when justified and compliant with NIH policy.

Administrative details from the listing include that this is a discretionary grant program in the health funding category administered by NIH, with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840. The opportunity was created on 2024-12-18, and the listed original closing date is 2027-01-07. The source excerpt does not specify an award ceiling or the expected number of awards, so applicants typically need to consult the full NOFO for budget limits, project period expectations, and other submission requirements.

• 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 2024-12-18.
• 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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