Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
Can you apply?
This grant is for early phase clinical trials developing therapeutics and/or diagnostics for heart, lung, blood, and sleep (HLBS) disorders. The NIH's R61/R33 mechanism supports translational research that bridges basic science and clinical application. Eligible applicants include research institutions, academic medical centers, hospitals, nonprofits, and small businesses with relevant scientific and clinical expertise. The grant prioritizes projects moving from preclinical or early clinical evidence toward human clinical trials. Geographic scope is nationwide; applicants must be domestic U.S. organizations. This funding supports the full development pathway from initial clinical feasibility (R61 phase) through expanded clinical validation (R33 phase), with a mandatory clinical trial component as part of the research plan.
This grant is for early phase clinical trials developing therapeutics and/or diagnostics for heart, lung, blood, and sleep (HLBS) disorders. The NIH's R61/R33 mechanism supports translational research that bridges basic science and clinical application. Eligible applicants include research institutions, academic medical centers, hospitals, nonprofits, and small businesses with relevant scientific and clinical expertise. The grant prioritizes projects moving from preclinical or early clinical evidence toward human clinical trials. Geographic scope is nationwide; applicants must be domestic U.S. organizations. This funding supports the full development pathway from initial clinical feasibility (R61 phase) through expanded clinical validation (R33 phase), with a mandatory clinical trial component as part of the research plan.
Program description
The objective of this funding opportunity is to support investigator-initiated, Phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. In addition to supporting clinical trial start-up and implementation activities, this FOA will provide support for final stage preclinical activities needed for the implementation of the proposed trial. All the activities proposed in the R61 phase must be directly related to the therapeutic/diagnostic in preparation for the clinical trial. The proposed trial can be single or multisite. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award where the first phase can be used to finalize required pre-trial activities such as stability, shipping studies, and site training.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for early phase clinical trials developing therapeutics and/or diagnostics for heart, lung, blood, and sleep (HLBS) disorders. The NIH's R61/R33 mechanism supports translational research that bridges basic science and clinical application. Eligible applicants include research institutions, academic medical centers, hospitals, nonprofits, and small businesses with relevant scientific and clinical expertise. The grant prioritizes projects moving from preclinical or early clinical evidence toward human clinical trials. Geographic scope is nationwide; applicants must be domestic U.S. organizations. This funding supports the full development pathway from initial clinical feasibility (R61 phase) through expanded clinical validation (R33 phase), with a mandatory clinical trial component as part of the research plan.
How to apply
Application links
Required documents
- NIH Form SF-424 (R&R) and SF-424 Supp
- Project Narrative (up to 6 pages of research strategy)
- Detailed Budget and Budget Justification (R61 and R33 phases shown separately)
- Biosketches of all key personnel (4 pages each)
- Literature Cited
- Budget Justification with justification for clinical trial costs
- Vertebrate Animals or Human Subjects approval documentation (IRB approval or approved protocol if available)
- Letters of support from clinical sites and collaborators
- Risk analysis and mitigation plan
- R61/R33 specific milestones and go/no-go criteria document
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.840 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$9,471,643
-
$8,728,007
-
$7,692,108
-
$4,748,073
-
$4,329,292
-
$3,974,800
-
$3,948,062
-
$3,945,932
-
$3,945,135
-
$3,868,722
Top States by Funding
- MA 7 awards $24.6M
- NY 5 awards $17.8M
- WA 5 awards $16.2M
- CA 8 awards $14.1M
- PA 6 awards $14.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.840). How funding has trended year over year.
| 2024 | $68,908,737 | |
| 2025 | $72,174,672 |
FAQ
Who can apply for this R61/R33 grant?
Domestic U.S. research institutions, academic medical centers, hospitals, biotech companies, and nonprofits with DUNS numbers and proper registration. Small businesses are encouraged to apply.
What is the R61/R33 mechanism?
The R61/R33 is a two-phase award. The R61 phase (typically years 1-2) funds feasibility and proof-of-concept for a therapeutic or diagnostic; the R33 phase (typically years 3-5) funds expansion and clinical validation. A go/no-go decision point occurs between phases.
Is a clinical trial mandatory?
Yes. This specific RFP requires a clinical trial component as part of the research plan. The trial may be Phase I, Phase II, or Phase I/II depending on the development stage.
What types of HLBS disorders are in scope?
Heart disease, hypertension, pulmonary conditions, blood disorders, hematologic diseases, sleep disorders, and related conditions. Projects should align with NHLBI research priorities.
How competitive is this grant?
Very competitive. Success rates for NIH R-series grants typically range from 15–25%. Applications need strong preliminary data, experienced teams, and feasible timelines.
💡 Tips for applicants
- Start with very strong preliminary data: reviewers expect proof-of-concept that justifies entry into clinical trials. Weak early evidence is the most common reason for rejection.
- Define your go/no-go decision criteria clearly between R61 and R33 phases so the review committee understands what success looks like and when to stop.
- Budget realistically for human subjects protection, regulatory approvals (IND/IDE), and clinical monitoring—these are expensive and often underestimated by first-time applicants.
- Assemble a multidisciplinary team with clinical co-investigators who have IRB/regulatory experience; applications without demonstrated clinical expertise often score poorly.
- Write your Specific Aims in plain language that justifies clinical relevance: explain why existing treatments are inadequate and why your approach could change patient outcomes.
⚠️ Common mistakes
Applicants often submit with insufficient preliminary data, leading reviewers to question whether the science is truly ready for human testing. Another frequent flaw is underestimating the timeline and budget for regulatory approval (IND/IDE), clinical trial setup, and patient recruitment—projects that look overly ambitious for the proposed budget score low on feasibility. Finally, teams lacking demonstrated clinical and regulatory expertise (IRB, FDA interactions) are viewed as higher-risk, even if the basic science is strong.
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