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

Frequently Asked Questions (FAQs)

What is the NHLBI Clinical Trial Pilot Studies funding opportunity (PAR-24-049)?

PAR-24-049 is a National Heart, Lung, and Blood Institute (NHLBI) funding opportunity that uses the NIH R34 mechanism to support focused pilot studies. The pilot work is intended to directly enable the design and planning of a later Phase II, III, or IV clinical trial that fits within NHLBI's mission areas (heart, lung, blood, and sleep disorders).

What is the main purpose of the R34 in this announcement?

The purpose is to generate information that is both necessary and sufficient to finalize the design and operational plan for a future Phase II to Phase IV clinical trial. The R34 should resolve key uncertainties so that the later clinical trial can be responsibly and efficiently launched without needing additional preliminary studies to settle the core design.

What does "necessary and sufficient" mean in the context of this pilot study?

It means the pilot should answer the specific questions that must be answered to finalize the later trial's protocol and operations. The expectation is that, once the R34 ends, the applicant can make clear design decisions for the Phase II-IV trial based on the pilot results, rather than having open-ended next steps or needing more feasibility work to define the main trial.

Does the R34 support generic feasibility studies?

No. This R34 is not intended for a broad or open-ended feasibility study with unclear follow-on plans. The pilot aims should be tightly linked to explicit decision points in the future Phase II-IV clinical trial.

What kind of future clinical trial must the R34 be designed to inform?

The planned future clinical trial must be a Phase II, Phase III, or Phase IV trial that primarily tests one or more interventions related to the prevention and/or treatment of heart, lung, blood, and sleep disorders, consistent with NHLBI priorities.

What types of trial questions can the later Phase II-IV study address?

The later trial can focus on efficacy and safety questions, clinical management strategies, or implementation approaches, as long as it aligns with NHLBI's mission and is positioned as a later-stage clinical trial (Phase II-IV).

Is this R34 meant to fund routine trial start-up or administrative preparation activities?

No. A key distinction in this announcement is that the R34 is not simply for administrative start-up activities or routine preparation tasks. It is intended to produce new scientific or operational knowledge that materially shapes the final design of the later trial.

Can the R34 focus on pragmatic, real-world operational issues?

Yes. The NOFO explicitly notes that the R34 questions may be pragmatic, including 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.

What are examples of high-impact design questions the R34 can address?

Examples provided include uncertainties that affect recruitment and retention, intervention delivery and fidelity, site readiness, outcome ascertainment and measurement logistics, adherence strategies, data collection workflows, safety monitoring approaches, and other practical elements that directly affect feasibility and interpretability of the future Phase II-IV trial.

What does "actionable evidence" mean for this R34?

It refers to pilot results that concretely guide the protocol and operational plan for the later Phase II-IV trial. The emphasis is on producing evidence that resolves major design risks, rather than collecting preliminary data that still leaves core design choices unresolved.

How should applicants describe the relationship between the R34 pilot and the future Phase II-IV trial?

Applicants are expected to clearly describe the future, larger clinical trial they intend to run and then justify why the specific pilot questions in the R34 must be answered to responsibly and efficiently launch that subsequent trial. Strong applications connect each pilot aim to a clear decision point in the later trial.

Does receiving an R34 award guarantee funding for the later Phase II-IV clinical trial?

No. Receiving an R34 award under this NOFO does not automatically lead to funding for the later Phase II-IV trial. The later trial will require a separate new application, and it will be evaluated independently on its own merits.

Should the R34 be written as a stand-alone project?

Yes. The R34 should be written as a self-contained project with deliverables that stand on their own, while also clearly enabling a well-justified and well-designed later-stage clinical trial application.

Who is eligible to apply for this opportunity?

Eligibility is broad and includes many domestic organizations and government entities, including 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; nonprofit organizations (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.

Are particular institution types explicitly highlighted as eligible?

Yes. The announcement 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).

Are foreign organizations eligible to apply as the applicant organization?

No. Foreign organizations (non-domestic entities) are not eligible to apply as applicant organizations under the information provided.

Are foreign components allowed in any form?

Yes. Non-domestic components of U.S. organizations are eligible, and foreign components are allowed under the NIH Grants Policy Statement definitions (as referenced in the provided information).

What federal agency and grant type is this?

This is a discretionary grant opportunity under the National Institutes of Health (NIH), in health-related activity categories, administered through NHLBI using the NIH R34 mechanism.

What CFDA numbers are associated with this opportunity?

The CFDA numbers listed are 93.233, 93.837, 93.838, 93.839, and 93.840.

When was this opportunity created, and what is the closing date shown?

The opportunity was created on 2023-11-03, and the original closing date shown in the provided listing is 2027-01-07.

Does the provided listing include an award ceiling or expected number of awards?

No. The provided source text states that it does not provide an award ceiling or expected number of awards. Applicants are directed to rely on the full NOFO and NIH guidance for budget expectations, project period limits, and application due dates tied to NIH receipt cycles.

What is the biggest "fit" signal for a strong application under this R34?

A strong fit is an applicant who already has a clear concept for a Phase II-IV clinical trial in heart, lung, blood, or sleep health, but needs a tightly scoped, high-yield pilot project to answer specific scientific or operational questions that would otherwise prevent a credible, final trial design.

What should reviewers be able to see clearly in a well-aligned R34 application?

They should be able to see how every pilot aim maps to an explicit decision point in the later Phase II-IV trial, and how the R34 outputs will finalize the protocol, reduce key risks, and enable a well-justified Phase II-IV clinical trial application.