Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed)
Funds observational studies in musculoskeletal, rheumatic, and skin diseases with simplified review changes, R01 clinical trials excluded.
Funder: National Institutes of Health
Due Dates: March 4, 2025 | July 2, 2025 | November 4, 2025 | March 4, 2026 | July 2, 2026 | November 2, 2026 (New, Renewal, Resubmission, Revision)
Funding Amounts: Up to $475,000 direct costs over 4 years; no more than $250,000 in any single year; maximum project period is 4 years.
Summary: Supports observational studies to inform the design of future clinical research in musculoskeletal, rheumatic, or skin diseases; clinical trials are not allowed.
Key Information: Only observational (non-interventional) studies are eligible; applications proposing clinical trials or basic/lab research will not be reviewed.
Description
This opportunity from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at NIH supports Research Project Grant (R01) applications for clinical observational (CO) studies in musculoskeletal, rheumatic, or skin diseases. The goal is to generate data necessary for designing future clinical studies, such as identifying disease progression, comorbidities, patient-relevant outcomes, and validating biomarkers or outcome measures. Only non-interventional, observational studies are eligible; clinical trials and basic laboratory research are not supported.
Studies may include:
- Characterizing disease symptoms and progression.
- Comparing biomarkers to established outcome measures.
- Testing recruitment strategies for rare or underserved populations.
- Collecting adverse event data from standard-of-care treatments.
- Gathering standard-of-care data for use as historical controls.
Applications must address significant obstacles or questions in clinical study design and are encouraged to use innovative methods (e.g., telehealth, digital outcomes, wearables). The diversity of the study cohort should reflect the affected population.
