This Funding Opportunity Announcement (FOA) encourages Research Project Grant (R01) applicants to pursue clinical observational (CO) studies to obtain data necessary for designing future clinical trials or studies for musculoskeletal, rheumatic, or skin diseases or conditions. Research data from observational cohort studies can enhance clinical study design by providing essential information about disease symptoms, stages and timing of disease progression, comorbid conditions, availability of potential clinical trial participants, and outcomes that are important to patients. CO studies also can facilitate efforts to develop and/or validate objective biomarkers or subjective outcome measures for use in a future trial or clinical study. Read the full PAR-21-053 funding opportunity announcement. 

Purpose

Applicants to this FOA are encouraged to propose studies that address significant obstacles or questions in the design of a clinical study, 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.

This initiative will support observational studies only, and will not support intervention studies, also called clinical trials. 

Research Area Examples

Specific examples of research areas of interest include but are not limited to:

• Characterization of the frequency and/or severity of disease associated symptoms that would be measured as an outcome in future clinical studies.
• Association studies that compare a biochemical or imaging biomarker to other, established outcome measures to establish surrogate markers.
• Testing of clinical study recruitment strategies for rare diseases or underserved populations that would be candidates for participating in a future clinical study.
• Collection of data on adverse events from administration of treatment under a standard of care setting in an observational study protocol that could be used to design a future clinical research study.
• Collection of standard of care data in an observational study setting to be used as a historical control for a future clinical research study.