Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed)

The Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases funding opportunity (PAR-24-280) from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports observational studies that aim to provide data critical for designing future clinical studies related to musculoskeletal, rheumatic, and skin diseases. This funding opportunity, issued under the R01 Research Project Grant mechanism, focuses exclusively on non-interventional studies. Such studies collect data through observation without altering patient care or treatment and are intended to address specific obstacles or gaps in clinical study design. Applicants are encouraged to propose studies that enhance the understanding of disease symptoms, stages, timing of progression, and comorbid conditions. These studies may also validate objective biomarkers, subjective outcome measures, or assess patient-reported outcomes for use in future clinical studies. Examples of research include characterizing disease symptoms to determine potential outcome measures, validating biomarkers or imaging tools, testing recruitment strategies for rare diseases, and gathering historical control data from standard-of-care treatments. While these studies are intended to inform future clinical trials or observational studies, the collected data may also directly influence clinical care. Ancillary observational components to existing studies are permitted, provided they do not include clinical trial elements. The total funding available is contingent upon NIH appropriations. Applicants may request a budget of up to $475,000 in direct costs over four years, with no more than $250,000 in any single year. Projects are limited to a four-year duration. Applications that propose NIH-defined clinical trials, early-stage biomarker discovery, animal studies, or pathophysiology research will be deemed nonresponsive and returned without review. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local and state governments, tribal governments, and other public entities. Foreign organizations are not eligible, but foreign components as part of a U.S.-based project are allowed. Applicants must be registered with the System for Award Management (SAM), eRA Commons, and Grants.gov to apply. The application process includes preparing a Research Strategy that describes how the proposed study addresses significant gaps or challenges in clinical research design. A subsection titled “Necessity for Future Clinical Research Study” is required, detailing how the observational study will inform future clinical research. Proposals must include plans for data management and sharing as per NIH policy. Applications will undergo a two-tier review process focusing on scientific merit, feasibility, and the qualifications of the research team and environment. Key review criteria include the significance of the proposed study, rigor and feasibility of the approach, and the expertise of investigators. Applications are due on March 4, July 2, and November 4 annually through November 2, 2026. Awards are expected to start as early as December 2025, depending on review cycles. For additional information, applicants are encouraged to contact designated NIAMS program officials based on the relevant disease area. This opportunity offers a valuable pathway for researchers to address key gaps in clinical study design through well-structured observational studies.