Feasibility Studies to Inform the Design of Future Clinical Trials
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for researchers and research institutions conducting preliminary feasibility studies that will directly inform the design of future clinical trials. Eligible applicants typically include academic medical centers, research universities, nonprofit research organizations, and government research facilities with institutional capacity to conduct rigorous feasibility research. The program supports activities in all U.S. states and territories. Funded feasibility studies may examine recruitment strategies, retention approaches, outcome measure validity, intervention delivery methods, population characteristics, or other research design questions that reduce risk before launching a full clinical trial. The goal is to generate critical data that improves clinical trial planning and increases the likelihood of successful trial implementation.
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Key dates
- Apr 28, 2026 Applications open
- Feb 16, 2027 Application deadline in 214 days
- Dec 1, 2027 Award announced
- Dec 1, 2027 Project start
Program description
The National Institutes of Health intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose feasibility studies that could inform the design and conduct of subsequent definitive clinical trials (e.g., efficacy, effectiveness, pragmatic, dissemination and implementation, phase/stage II or later trials). Applications to this NOFO should demonstrate that the proposed feasibility research is scientifically necessary to design or plan the subsequent definitive clinical trial. Studies may utilize mixed methods and feasibility clinical trials to assess feasibility of recruitment, randomization, retention, intervention delivery, data collection, adherence, acceptability, and/or develop or adapt intervention components or protocols. The proposed feasibility research should enhance the rigor and reproducibility of the future trial methods. The subsequent definitive clinical trial should have the potential to make a significant impact on public health.
Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Investigators with expertise in clinical trial planning, design, implementation, intervention development, and/or stakeholder engagement are encouraged to begin to consider applying for this new NOFO.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- NIH SF-424 (R&R) application form
- Project narrative describing feasibility study aims, methods, and connection to future clinical trial
- Detailed budget and budget narrative
- Biographical sketches of key personnel (NIH format)
- Institutional commitment and facilities documentation
- Letters of support from collaborating sites (if applicable)
- Data safety plan (if applicable)
- Conflict of interest disclosures
Program contact
- 👤 NCCIH Division of Extramural Research Program Officer
- 📧 NCCIHDERFunding@nih.gov
- 📞 Please contact via e-mail
Funding track record
Recent awards under CFDA 93.213 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$22,367,527
-
$21,646,919
-
$19,236,131
-
$17,730,528
-
$15,036,701
-
$14,473,882
-
$12,748,932
-
$11,956,053
-
$11,225,697
-
$10,919,780
Top States by Funding
- CA 13 awards $83.5M
- MA 13 awards $80.2M
- WA 8 awards $69.9M
- NC 7 awards $53.8M
- NY 6 awards $40.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.213). How funding has trended year over year.
| 2024 | $240,178,154 | |
| 2025 | $232,899,116 | |
| 2026 est. | $2,655,626 |
FAQ
Who is eligible to apply for this feasibility study grant?
Research institutions including academic medical centers, universities, nonprofit research organizations, and other entities with capacity to conduct rigorous research are typically eligible. Individual researchers should apply through their institutional research office.
What types of feasibility studies are supported?
Studies examining recruitment feasibility, retention strategies, outcome measure validation, intervention delivery logistics, population assessment, or other research design questions that inform future clinical trial development.
Is there a required budget minimum or maximum?
NIH R21 awards (the typical mechanism for feasibility studies) typically fund $275,000-$325,000 over two years, though amounts vary by institute. Check the specific RFP for exact limits.
How competitive is this grant?
Very competitive. Expect strong competition from established research institutions and experienced clinical trial investigators. Your feasibility study must clearly show how findings will directly impact a planned clinical trial's design.
When are typical application deadlines?
Standard NIH deadlines are typically in February, June, and October each year, though this can vary. Confirm the deadline for your funding cycle in the official RFP.
💡 Tips for applicants
- Clearly articulate the future clinical trial you're planning and explain specifically how your feasibility study findings will change its design, sample size, recruitment strategy, or other critical elements.
- Demonstrate preliminary data or pilot work showing that your research question is meaningful and feasible; reviewers want confidence you can complete the proposed work.
- Design the feasibility study to answer one or two critical questions about trial implementation, not to serve as a full pilot efficacy study; focus on design decisions, not efficacy claims.
- Include a detailed timeline showing how you'll conduct the feasibility work and disseminate findings quickly so they can meaningfully inform your next trial.
- Identify and budget for a strong multidisciplinary team including clinical experts, biostatisticians, and research coordinators with demonstrated experience in clinical trials.
⚠️ Common mistakes
Applicants often fail to clearly link their feasibility study to a specific, well-conceived future clinical trial, making reviewers question the relevance of proposed work. Another frequent misstep is proposing a full pilot efficacy study rather than a focused feasibility investigation that answers one or two design questions. Finally, weak preliminary data or unclear evidence that the feasibility work is actually needed weakens competitiveness significantly.
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