Clinical Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) (PAR-24-036)

The purpose of this Notice of Funding Opportunity (NOFO) is to encourage Research Project Grant (R01) applications to pursue clinical observational (CO) studies to obtain data necessary for designing clinical studies for musculoskeletal, rheumatic, or skin diseases or conditions. Research data from observational studies supported by this NOFO can enhance clinical study design by providing essential information about disease symptoms, stages, and timing of disease progression; comorbid conditions; availability of potential research participants; and outcomes that are important to patients. They also can facilitate efforts to develop and/or validate objective biomarkers or subjective outcome measures for use in a future clinical study. A future clinical study may include a clinical trial or an observational study. Applicants to this NOFO are encouraged to propose studies that address significant obstacles or questions in the design of a clinical project, such as determining the appropriate primary or secondary outcome measures or identifying the stages of disease during which patients are most likely to respond to an intervention. Only observational studies will be supported through this NOFO.