PAR-24-280
Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed)
Summary
Clinical Observational Studies in Musculoskeletal, Rheumatic, and Skin Diseases
Research Focus
This PAR-24-280 supports R01 Research Project Grants for clinical observational studies designed to generate foundational data for planning future clinical research in musculoskeletal, rheumatic, and skin diseases. The program targets studies that characterize disease presentation, progression, and patient-relevant outcomes without experimental intervention—researchers observe and collect data on enrolled participants' health characteristics, biospecimens (for biomarker or genomic analyses), imaging, and medical history. Priority research areas include documenting symptom frequency and severity, validating objective biomarkers or subjective outcome measures against established comparators, testing recruitment strategies for rare diseases or underserved populations, and collecting standard-of-care adverse event or historical control data to inform future clinical study design. Applications leveraging telehealth, digital outcomes, or wearable devices are encouraged. The intended contribution is to reduce design uncertainty and identify appropriate outcome measures, disease stages responsive to intervention, and participant availability before launching confirmatory clinical research.
At a Glance
- Who can apply: U.S. higher education institutions, nonprofits, for-profit organizations, state/local/tribal governments, and federal agencies. Foreign organizations are not eligible; foreign components of U.S. organizations are allowed.
- Funding & project length: Up to $475,000 direct costs over four years (maximum $250,000 per year); project period determined by scope, maximum four years.
- Award mechanism: R01 Research Project Grant (clinical trials not allowed; observational studies only).
- Key dates: Open February 4, 2025; rolling due dates March 4, 2025 onward (multiple cycles through November 2026); earliest start July 2025.
- Best fit for: Clinical researchers in rheumatology, orthopedics, dermatology, and related fields conducting prospective or retrospective cohort studies, cross-sectional surveys, or observational ancillary studies with diverse participant enrollment.
Key Facts
Deadline
Mon, November 2, 2026
Posted
Mon, December 9, 2024
Award / Year (direct costs)
$250,000
Max Total
$475,000
Max Duration
4 years
Keywords
Research Areas
Gotchas (5)
Only observational studies are supported; clinical trials are explicitly not allowed. Applications proposing any NIH-defined clinical trials will be returned without review.
99%
Source Text
“Only CO studies will be supported through this NOFO... Any NIH-defined clinical trials... Non-responsive applications will be returned without review.”
Enrollment must match the diversity of the population affected by the disease, or the application may be considered low priority. This is a subjective criterion that could affect priority scoring.
85%
Source Text
“Enrollment for the proposed study cohort should match the diversity of the population affected by the disease, otherwise the application may be considered low priority by the NIAMS.”
Budget is capped at $475,000 total over four years with a maximum of $250,000 in any single year. This is a strict annual cap that may constrain project scope.
95%
Source Text
“Direct costs are limited to $475,000 over the four-year period [exclusive of consortium/subcontractual Facilities and Administrative (F&A) costs] with no more than $250,000 in any single year.”
Studies on blood or tissue samples collected independently of the proposed project are not responsive and will be returned without review. This excludes secondary analysis of existing biospecimens.
95%
Source Text
“Studies on blood or tissue samples derived from human subjects, that are collected independently of the proposed project.”
FOA permits 'observational additions to ongoing clinical studies' and 'ancillary observational additions' but does not define these terms or clarify how they differ from prohibited clinical trials
90%
Source Text
“Observational additions to ongoing clinical studies that are not clinical trials are permitted. Such permissible studies may include collecting data on patients who receive treatment as part of their standard of care, not as part of a research study protocol. Ancillary observational additions to ongoing clinical studies are permitted.”