NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required) | PAR 21 118

FAQs: NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required) - PAR-21-118

What is PAR-21-118?

PAR-21-118 is an NIH/NHLBI funding opportunity that supports investigator-initiated phase I clinical trials testing new or early-stage therapeutic and/or diagnostic interventions relevant to heart, lung, blood, and sleep (HLBS) disorders. It uses the R33 mechanism and requires a clinical trial.

What stage of clinical research does this funding support?

This opportunity is designed for phase I clinical trials, including first-in-human or other early clinical testing. The focus is on early signals appropriate for phase I work, such as initial safety, tolerability, feasibility, and similar early outcomes.

What types of interventions are supported?

The FOA supports early-stage therapeutic and/or diagnostic interventions. The description emphasizes interventions that are ready for early clinical testing rather than those needing lengthy preclinical development.

What disease or research areas are in scope?

Projects must be relevant to heart, lung, blood, and sleep (HLBS) disorders, consistent with NHLBI program priorities described for this FOA.

Are both adult and pediatric studies allowed?

Yes. The FOA applies to studies in both adult and pediatric populations.

Can the trial be single-site or does it need to be multisite?

Either is allowed. Trials may be structured as single-site or multisite projects, giving flexibility to align the design with recruitment needs, specialized procedures, or the nature of the intervention or diagnostic.

What does "clinical trial required" mean for this R33?

It means the award is intended to support the conduct of a clinical trial and that the application is expected to include a clinical trial as part of the proposed work.

What is the FOA's expectation for trial readiness at the time of award?

A defining feature of this FOA is immediate trial readiness. Applicants are expected to be able to initiate the clinical trial within the first quarter of the project period, meaning the project should be positioned to start quickly after award rather than spending early months on major startup activities.

How quickly does NHLBI expect the trial to start after funding begins?

The FOA indicates the clinical trial should be able to start within the first quarter of the project period. Practically, that implies rapid initiation soon after award.

Is this FOA intended to pay for lengthy preclinical development?

No. The FOA message is that it is not intended to fund lengthy preclinical development or extended trial setup. It is intended to fund the conduct of the phase I trial itself when the team is ready to move.

What regulatory and oversight items are expected to be ready by award (as applicable)?

The FOA expects major regulatory and administrative prerequisites to be ready by award, as applicable. This includes FDA-related interactions and submissions (such as IND or IDE and necessary communications), IRB review and approval, and Data and Safety Monitoring Board (DSMB) planning and approvals when required.

Does the FOA expect FDA IND or IDE activity to be underway or completed?

Yes, where applicable. The FOA specifically references FDA-related interactions and submissions, including IND or IDE and any necessary communications, as part of being trial-ready by the time of award.

Is IRB approval expected before the award is made?

The FOA describes expectations that IRB review and approval are well underway or completed and that major prerequisites will be ready by award, indicating that IRB readiness is part of the immediate start requirement.

When is a DSMB expected, and what is required regarding DSMB planning?

When required for the study, the FOA expects DSMB planning and approvals to be ready by award as part of the trial-readiness posture.

What operational preparations are expected before award?

Operational details should be sufficiently mature that enrollment and study procedures can begin quickly. The FOA emphasizes that key startup elements should already be in place or ready by award to enable a fast start.

Are drug supply and placebo logistics expected to be settled before award?

Yes. The FOA states that applicants are expected to have drug supply logistics settled, including placebo when relevant.

Are third-party agreements expected to be arranged before award?

Yes. The FOA indicates essential third-party agreements should be arranged, such as contracts with manufacturers, central labs, imaging core facilities, clinical sites, or other vendors, as part of being ready to initiate quickly.

If our project is not ready to start a phase I trial quickly, what is the alternative?

NHLBI points applicants who are not yet at that level of readiness to a companion opportunity that uses an R61/R33 phased approach. The phased mechanism supports remaining preclinical and trial-readiness activities first (R61) and then transitions into the clinical trial phase (R33) once milestones are met.

How should an applicant decide between PAR-21-118 (R33) and the companion R61/R33 mechanism?

Based on the description provided: PAR-21-118 is the better fit when the intervention is ready for early clinical testing now and the team can start the trial quickly after award. The R61/R33 companion is the better fit when additional time and support are still needed to complete critical enabling work and finalize readiness before launching the trial.

Who is eligible to apply?

Eligibility is broad and includes many organization types: state, county, and local 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; tribal organizations (including those other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses.

Are institutions serving specific communities explicitly included in eligibility?

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

Can a foreign (non-U.S.) institution apply as the primary applicant?

No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization for this opportunity.

Can a U.S. applicant include foreign collaborators or foreign activities?

Yes, within limits described. Non-domestic components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement. This means a U.S.-based applicant may include certain foreign activities or collaborators when justified, but a foreign institution cannot serve as the primary applicant.

Which agency administers this opportunity?

The opportunity is administered by the National Institutes of Health (NIH), specifically the National Heart, Lung, and Blood Institute (NHLBI), as described in the provided information.

What funding category is this grant listed under?

In the source details provided, it is categorized as a discretionary grant within the health funding activity category.

What CFDA numbers are associated with this FOA?

The CFDA numbers listed in the provided extract include 93.233 and 93.837 through 93.840.

What is the closing date shown in the provided record?

The record indicates an original closing date of 2024-01-07.

What is the creation date shown in the provided record?

The record shows a creation date of 2021-01-15.

Is there information provided on the award ceiling or the expected number of awards?

No. In the provided extract, the award ceiling and expected awards are not specified.

What is the overall "best fit" summary for this FOA?

This FOA is best understood as a fast-start mechanism for investigators who already have their phase I HLBS clinical trial positioned to begin promptly, with regulatory, supply, and operational foundations substantially completed by the time the award is issued.