Early to Definitive Clinical Trials (R61/R33 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 18, 2026
Can you apply?
This grant is for research institutions and individual researchers planning early-to-definitive clinical trials funded by NIH. Applicants must propose trials of drugs, devices, biologics, procedures, behavioral, social, economic, health services, or non-pharmacological interventions. The trial must align with the research mission of participating NIH Institutes, Centers, and Offices (ICOs).
The R61/R33 award is a two-phase mechanism. The R61 phase supports planning and trial design (including intervention development and stakeholder engagement). The R33 phase funds the actual clinical trial execution. Total project period may last up to 7 years across both phases.
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Key dates
- Sep 29, 2026 Applications open
- Jul 31, 2027 Application deadline in 285 days
- Apr 30, 2028 Award announced
- Apr 30, 2028 Project start
Program description
The National Institutes of Health (NIH) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose early to definitive clinical trials. Trials testing drugs, devices, biologics, procedures, behavioral, social, economic, health services, or other biomedical or non-pharmacological interventions are of interest to this initiative. The trials should align with the research mission of the participating Institutes, Centers, and Offices (ICOs) of the NIH.
The NOFO will utilize the R61/R33 activity code, a bi-phasic, milestone-driven award. The R61 phase provides support for planning activities, and the R33 phase provides support for a clinical trial, with a maximum project period of 7 years.
Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and relevant projects. Investigators with expertise in clinical trial planning, design, implementation, intervention development, and/or stakeholder engagement are encouraged to consider applying for the NOFO.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- Standard NIH grant application forms (SF-424 R&R)
- Project narrative and specific aims
- Detailed trial design and protocol
- Preliminary data or evidence of intervention feasibility
- Budget and budget justification
- Biosketches of key personnel
- Letters of support from collaborators or trial sites
Program contact
- 👤 NIA Scientific Program Contact
- 📧 NIA-NOFO-Scientific@nih.gov
- 📞 Please contact via e-mail
Funding track record
Recent awards under CFDA 93.866 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$463,372,200
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$199,819,363
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$148,130,300
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$113,990,692
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$109,670,101
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$102,150,671
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$89,954,729
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$85,658,817
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$81,449,732
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$80,730,785
Top States by Funding
- CA 10 awards $673.7M
- MI 2 awards $528.1M
- MO 8 awards $476.4M
- IN 4 awards $328.1M
- PA 6 awards $323.7M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.866). How funding has trended year over year.
| 2024 | $3,746,886,731 | |
| 2025 | $3,777,464,644 | |
| 2026 est. | $261,814,471 |
FAQ
Who can apply for this grant?
Researchers at institutions eligible to receive NIH funding can apply. Applicants need expertise in clinical trial planning, design, implementation, or stakeholder engagement.
What is the R61/R33 mechanism?
It is a two-phase award. The R61 funds planning and trial design (typically earlier phase). The R33 funds the actual clinical trial, with a combined project period up to 7 years.
What types of interventions are eligible?
Trials may test drugs, devices, biologics, procedures, behavioral interventions, social/economic interventions, health services, or other biomedical approaches. The trial must align with an NIH Institute or Center's research mission.
When is the deadline?
Applications are not being solicited at this time. This notice is for planning purposes. Watch for a future Notice of Funding Opportunity (NOFO) announcement.
Do I need cost-sharing or matching funds?
No cost-sharing is required for this grant.
💡 Tips for applicants
- Start building your research team and stakeholder partnerships now. The notice provides planning time before formal applications open.
- Ensure your trial design aligns with a specific NIH Institute or Center's research priorities. Review ICO strategic plans before applying.
- The R61 phase is your planning opportunity. Use it to develop robust trial protocols, secure stakeholder input, and address feasibility concerns.
- Include co-investigators or collaborators with clinical trial expertise. Reviewers value experienced trial teams.
- Prepare detailed intervention descriptions and rationale. Clearly explain why your intervention warrants a definitive clinical trial.
⚠️ Common mistakes
Proposing a trial without clear alignment to an NIH Institute's research mission. Weak or underdeveloped intervention rationale without prior preliminary data. Underestimating planning needs in the R61 phase or proposing insufficient milestones for phase progression.
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