Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
Can you apply?
This grant is for researchers and institutions conducting early-stage clinical trial research focused on heart, lung, blood, and sleep disorders. Eligible applicants include academic research institutions, medical centers, and 501(c)(3) nonprofit organizations with research capabilities. The grant supports pilot studies that generate preliminary data for larger National Heart, Lung, and Blood Institute (NHLBI) clinical trials. U.S.-based institutions and investigators are eligible; foreign organizations may apply if they have U.S. federal funding eligibility.
Principal investigators must hold an M.D., Ph.D., D.O., or equivalent doctoral degree. Early-career researchers and established investigators are both encouraged to apply. This mechanism is specifically designed to test novel clinical trial approaches and build evidence before seeking major NHLBI funding.
Geographic scope includes all 50 U.S. states, territories, and D.C. Research may focus on any condition within NHLBI's disease scope: cardiovascular disease, lung disease, blood disorders, and sleep disorders.
Program description
This Notice of Funding Opportunity Announcement (NOFO) intends to supports studies that are both necessary and sufficient to inform the planning of a Phase II-IV clinical trial within NHLBI’s mission. The NHLBI expects that applications to this NOFO will describe the planned clinical trial and in so doing demonstrate that the proposed (R34) research is scientifically necessary to design or plan the subsequent trial. Furthermore, this NOFO will support research projects that are designed to provide results that will be sufficient to inform the future trial without further studies. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and/or treatment of heart, lung, blood, and sleep disorders. In contrast to the study start up or preparation phase of NHLBI funding opportunities for clinical trials (as described at https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization), the R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial. Regardless of the results of the R34, support of the proposed future clinical trial will require a new application.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- SF-424 (R&R) Form
- Project Narrative (research plan)
- Budget narrative and detailed budget
- Biographical sketches of key personnel
- Letters of support from collaborating institutions
- Clinical trial protocol (if applicable)
- Data management and analysis plan
- Letter from Institutional Biosafety Committee (if applicable)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.838 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$64,183,283
-
$53,344,199
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$43,989,024
-
$38,428,037
-
$34,243,478
-
$27,859,190
-
$26,861,834
-
$26,624,924
-
$26,063,829
-
$25,153,102
Top States by Funding
- MA 14 awards $246.9M
- CA 15 awards $199.1M
- CO 8 awards $139.0M
- IL 7 awards $107.8M
- NC 4 awards $95.8M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.838). How funding has trended year over year.
| 2024 | $760,925,134 | |
| 2025 | $789,408,855 |
FAQ
Who can be the principal investigator on this grant?
Investigators with M.D., Ph.D., D.O., or equivalent doctoral degrees are eligible. Early-career researchers and experienced investigators can both apply.
What types of institutions qualify to apply?
Academic medical centers, research universities, nonprofit organizations, government agencies, and state/local institutions with 501(c)(3) or equivalent status are eligible. Federal agencies may also apply.
What research activities does this grant support?
This funds pilot clinical trials, preliminary clinical trial design work, and feasibility studies. It generates data for larger NIH clinical trial applications. Research must focus on NHLBI disease areas.
How competitive is this mechanism?
R34 mechanisms are moderately competitive. Strong preliminary data, a clear clinical trial design, and an experienced team improve chances. Success rates typically range 15-25% for NHLBI R34 funding.
What is the typical funding amount and project duration?
Awards typically support 2-year projects. Budget caps are usually $275,000-$450,000 total costs depending on complexity. Check the current funding opportunity announcement for exact limits.
💡 Tips for applicants
- Develop strong preliminary data now. Reviewers expect pilot results showing feasibility before you apply. Start your pilot work early.
- Design a realistic, achievable clinical trial plan. Show clear milestones and timelines for your 2-year pilot. Overly ambitious proposals often fail.
- Assemble a multidisciplinary team with relevant expertise. Include biostatisticians, clinical coordinators, and content experts. Team strength matters significantly.
- Address feasibility head-on. Discuss patient recruitment, retention, and site capacity. Be honest about potential barriers and your solutions.
- Follow the NIH formatting and structural requirements exactly. Use the correct modular budget form and include all required sections. Non-compliance is an automatic disadvantage.
⚠️ Common mistakes
Lack of preliminary data. Reviewers reject proposals without evidence your pilot work is feasible. Start generating pilot results now.
Unclear clinical trial design. Applications must include specific aims, primary endpoints, and sample size justification. Vague designs are rejected quickly.
Overestimating budget and timeline. Proposing unrealistic budgets or claiming too much gets accomplished in 2 years signals inexperience.
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