This Funding Opportunity Announcement (FOA) encourages Research Project Grant (R01) applicants to pursue clinical observational (CO) studies to obtain data necessary for designing clinical trials for musculoskeletal, rheumatic, or skin diseases or conditions. Research data from observational cohort studies can enhance clinical trial 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 trials. Read the full PAR-18-597 funding opportunity announcement.
Applicants to this FOA are encouraged to propose studies that address significant obstacles or questions in the design of a clinical trial, 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:
- Characterizing the frequency and/or severity of disease associated symptoms that would be measured as an outcome in a future trial.
- Correlation studies comparing a biochemical or imaging biomarker to other, established outcome measures to establish surrogate markers.
- Testing clinical study recruitment strategies for rare disease or underserved populations that would be candidates for participating in an expected future trial.
- Collecting adverse event information during standard of care administration in an observational study setting to be included in the design (e.g., entry criteria, investigator's brochure) for a future clinical trial.
- Collecting standard of care data in an observational study setting to be used as a historical control for a future clinical trial.