Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for biomedical researchers and institutions seeking to conduct early-stage exploratory clinical trials focused on arthritis, musculoskeletal diseases, and skin diseases. Eligible applicants include research institutions, universities, hospitals, and other organizations with the infrastructure to conduct NIH-funded clinical research. The R61 mechanism is designed to support high-risk, high-reward clinical trial projects that are innovative but have limited preliminary data. Geographic scope is nationwide. Supported activities include trial design development, protocol development, feasibility testing, and initial patient enrollment. Applicants must have access to appropriate patient populations and institutional review board oversight. International collaboration is permitted under NIH guidelines.
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Program description
This Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required) PAR, a re-issue of PAR-24-035, was re-issued as a result of the Simplifying Review of Research Project Grant Applications [link: https://grants.nih.gov/policy-and-compliance/policy-topics/peer-review/simplifying-review].
The Simplify Review changes in Section V are the only changes that have been made. All other aspects of this funding opportunity remain the same.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- NIH Form SF-424 R&R (Application for Federal Assistance)
- Project Narrative/Research Plan (typically 15 pages maximum)
- Specific Aims (1 page)
- Research Strategy section including Significance, Innovation, and Approach
- Clinical Trial Budget with detailed justification
- Biographical Sketches (NIH format) for all key personnel
- Institutional support documentation (institutional commitment letter)
- IRB approval or pending review documentation
- Letters of support from clinical trial sites or patient recruitment partners
- Previous research support documentation (if applicable)
- Resource Sharing Plans (data management, clinical trial data sharing)
- Statistical analysis plan and biostatistical support letter
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.846 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$63,962,483
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$60,038,896
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$34,166,872
-
$27,648,731
-
$24,598,295
-
$21,654,386
-
$20,225,012
-
$16,326,540
-
$15,274,546
-
$14,828,008
Top States by Funding
- CA 13 awards $124.1M
- MA 15 awards $123.0M
- NY 12 awards $107.4M
- NC 4 awards $102.5M
- PA 11 awards $101.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.846). How funding has trended year over year.
| 2018 | $476,478,975 | |
| 2019 | $490,084,446 | |
| 2020 | $505,547,334 | |
| 2021 | $509,241,630 | |
| 2022 | $499,786,367 | |
| 2023 | $548,439,000 | |
| 2024 est. | $545,593,000 | |
| 2025 est. | $541,712,000 |
FAQ
Who is eligible to apply for this grant?
Research institutions, universities, hospitals, medical centers, and other organizations with NIH institutional support (DUNS number, CLIN, and institutional review board) are eligible. Individual researchers must be affiliated with eligible institutions.
What is the deadline for this grant?
The current deadline is November 2, 2026, with applications opening December 9, 2024. NIH typically has multiple submission deadlines per year for R-series mechanisms; check for earlier deadlines if applicable.
What types of clinical trial activities are supported?
This R61 mechanism supports exploratory clinical trial projects including protocol development, feasibility testing, preliminary efficacy/safety data collection, patient recruitment and retention studies, and proof-of-concept trials in arthritis, musculoskeletal, and skin disease research.
How competitive is this funding?
R61 grants are moderately to highly competitive. Success rates for NIH clinical trial grants typically range from 15-25%, depending on the specific institute and research focus. Strong preliminary data, innovative trial design, and clear scientific rationale are essential.
What is the typical funding range?
R61 grants typically award between $150,000-$400,000 per year depending on research scope, though applicants should consult the funding announcement for specific funding caps and expectations for clinical trial budgets.
💡 Tips for applicants
- Emphasize the innovation and risk-taking nature of your clinical trial design; R61 grants reward creative approaches to challenging research questions, so clearly articulate why your approach differs from existing trials.
- Develop a robust and realistic timeline for patient recruitment and retention, including specific strategies and partnerships with clinical sites; feasibility in human subjects research is a major evaluation criterion.
- Build strong institutional support by demonstrating commitment from your institution, including IRB approval status, biostatistical support, and data management infrastructure for clinical trial operations.
- Address regulatory and operational challenges head-on in your application; explain how you will handle patient safety monitoring, adverse event reporting, and regulatory compliance throughout the trial.
- Include a clear transition plan showing how successful R61 completion will lead to R33 funding (the follow-on phase) or other external funding to expand the clinical trial, demonstrating sustainability beyond the exploratory phase.
⚠️ Common mistakes
Applications often fail because they lack sufficient preliminary data to support the feasibility of the proposed clinical trial or present overly ambitious recruitment/enrollment targets without documented evidence of access to the patient population. Reviewers frequently cite inadequate attention to regulatory requirements, insufficient detail on trial safety monitoring plans, or weak justification for why this exploratory trial is needed when existing published trials already address the research question.
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