NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required) | PAR 25 025

Frequently Asked Questions (FAQs)

What is PAR 25-025 (NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders, R33 CT Required)?

PAR 25-025 is an NIH/NHLBI funding opportunity that supports investigator-initiated Phase I clinical trials for new therapeutics and/or diagnostics targeting heart, lung, blood, and sleep (HLBS) disorders. It uses the R33 mechanism and requires a clinical trial.

What types of studies does this program support?

This program supports Phase I clinical trials focused on early-stage clinical evaluation of therapeutics and/or diagnostics for HLBS disorders. The emphasis is on generating foundational clinical data to determine whether an intervention should advance to later-phase testing.

What are the main goals or endpoints emphasized for supported trials?

The primary emphasis is on early safety, tolerability, dosing, feasibility, and other foundational clinical data needed to inform go/no-go decisions for later-phase trials.

Does the program support both adult and pediatric trials?

Yes. The opportunity supports Phase I clinical trials in both adults and children, as long as the trial addresses HLBS disorders and fits the program scope.

Are diagnostics eligible, or is the program only for therapeutics?

Both are eligible. The opportunity is intended to support Phase I clinical trials that test new therapeutics and/or diagnostics for HLBS disorders.

Can a trial be single-site or must it be multi-site?

Either is allowed. Trials may be designed as single-site or multi-site studies, which allows applicants to size the operational footprint based on the condition, target population, recruitment needs, and practical execution considerations.

What does "CT Required" mean in this announcement?

It indicates that a clinical trial is required under this funding opportunity and the application is expected to propose a clinical trial consistent with the Phase I focus described in the announcement.

What is the defining expectation of this R33 mechanism for this opportunity?

A defining feature is immediate trial readiness. Applicants are expected to be prepared to initiate the clinical trial within the first quarter of the project period, meaning the work should be close to enrolling participants soon after award.

How soon is the trial expected to start after award?

The announcement expects the clinical trial to be ready to start within the first quarter of the project period. This implies that most major readiness work should be completed by the time the award is made.

Is this opportunity appropriate for teams still doing early development or trial planning?

Not generally. The NOFO is positioned for groups that do not need substantial preclinical development time or extensive clinical trial readiness work during the award period.

If our project is not yet ready to launch a Phase I trial, is there an alternative mentioned?

Yes. If enabling activities still need to be completed before a Phase I trial can responsibly begin, the opportunity directs applicants to consider a companion announcement using an R61/R33 phased approach.

What kinds of "enabling activities" are examples of work better suited to the R61/R33 phased approach (as referenced here)?

Examples mentioned include final formulation work, device refinement, completion of key toxicology, finalization of manufacturing, and other readiness tasks that must be finished before transitioning into the clinical trial phase.

What regulatory interactions or submissions are expected by the time of award?

The notice stresses that key regulatory milestones should be in place by award, including necessary discussions and submissions to regulators as applicable. It specifically references FDA interactions for IND/IDE-related work when required.

Are IRB approvals and oversight arrangements expected to be in place by award?

The announcement highlights the expectation that required approvals and oversight structures are aligned by the time the award is made, including Institutional Review Board (IRB) review.

Is a Data and Safety Monitoring Board (DSMB) required?

The opportunity notes DSMB arrangements should be in place when appropriate for the risk level and design. Whether it is appropriate depends on the trial design and risk profile as contemplated in the announcement.

What operational logistics are expected to be established by award?

The notice emphasizes that drug supply logistics (and placebo supply, if relevant) and needed third-party agreements should be established by award rather than treated as early-year activities.

What kinds of third-party agreements are referenced as needing to be in place?

Examples include contracts or agreements with manufacturers, central laboratories, imaging core facilities, clinical research organizations (CROs), or collaborating sites.

Who is eligible to apply?

Eligibility is broad and includes many domestic (U.S.) organization types and governmental entities, including state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status, other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and federally recognized Native American tribal governments, as well as tribal organizations that are not federally recognized tribal governments.

Does the NOFO explicitly encourage participation from specific institution types or communities?

Yes. It explicitly calls out additional eligible applicant types including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Can a foreign (non-U.S.) organization apply as the main applicant?

No. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization.

Are any foreign activities allowed under this opportunity?

Yes, in limited form. Non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined by the NIH Grants Policy Statement. A U.S.-based applicant may include foreign components or activities when well-justified, but a foreign organization cannot be the primary applicant.

Which NIH institute is sponsoring this opportunity?

The opportunity is sponsored by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH).

What is the activity category and assistance type for this funding opportunity?

Based on the provided metadata, it is a discretionary grant program under NIH with Health as the activity category.

What CFDA numbers are associated with this opportunity?

The opportunity is tied to CFDA numbers 93.233, 93.837, 93.838, and 93.839.

What is the maximum award amount (award ceiling) listed?

The listed award ceiling is $1,515,000.

What is the closing date shown for this opportunity?

The opportunity's original closing date is January 7, 2027.

What kind of project team is this opportunity best suited for?

It is best suited to well-prepared teams with a clearly defined Phase I clinical trial in HLBS conditions and a near-launch-ready study package, with regulatory, oversight, supply chain, and contracting elements sufficiently mature to begin the trial quickly after funding starts.