Clincal Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed) | PAR 18 597

Opportunity Information: Apply for PAR 18 597

This grant opportunity (PAR-18-597) is a National Institutes of Health (NIH) Research Project Grant (R01) funding announcement focused specifically on clinical observational (CO) research in musculoskeletal, rheumatic, and skin diseases or related conditions. The core purpose is to support studies that collect and analyze real-world clinical and patient data in order to generate the practical evidence needed to design stronger future clinical studies. Those later studies could be either clinical trials or additional observational work, but this particular FOA will only fund observational research and explicitly does not allow clinical trials under this mechanism.

The program is built around the idea that many intervention studies fail or stall because basic design questions are not answered well enough up front. NIH is looking for observational cohort-style projects that clarify things like how a disease presents and evolves over time, what meaningful stages of progression look like, when symptoms change, and how common or influential comorbidities are. It also emphasizes learning what outcomes matter most to patients (for example, pain, function, fatigue, flare frequency, quality of life, skin severity, mobility, ability to work, or other patient-prioritized endpoints) so that later interventional studies measure the right things and do so at the right times.

A major theme is de-risking and optimizing the design of future clinical studies. Applicants are encouraged to use observational approaches to tackle specific obstacles that commonly complicate clinical research planning, such as selecting appropriate primary and secondary outcome measures, determining which patient subgroups or disease stages are most likely to respond to a future intervention, estimating recruitment feasibility and participant availability, and identifying the most informative follow-up intervals. In practice, this could include efforts like mapping trajectories of disease activity, identifying predictors of progression or flare, characterizing heterogeneity across patient populations, or determining baseline factors that influence outcomes and could be used for stratification in later trials.

The FOA also highlights the value of observational studies for developing or validating measurement tools needed for future clinical work. This includes objective biomarkers (for example, lab markers, imaging features, molecular signatures, digital measures) and subjective outcome measures (such as patient-reported outcome instruments, clinician-reported scales, or composite indices). The intent is that these measures, once better established through observational data, can be used confidently in subsequent clinical studies where endpoint selection and measurement quality are critical.

Eligibility is broad and includes many types of U.S.-based organizations and governments, such as state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private higher education institutions; independent school districts; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations (including those other than federally recognized tribal governments); nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses); small businesses; and other eligible entities. The announcement also calls out additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving institutions, HBCUs, tribally controlled colleges and universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Foreign institutions (non-U.S. entities) are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, meaning a U.S. applicant can include certain international elements when they fit NIH policy definitions and are well-justified within the overall project.

Administratively, this is a discretionary grant in the health funding category (CFDA 93.846) administered by NIH. The original closing date listed for the opportunity was 2020-11-03, and an award ceiling of $225,000 is provided in the source details. Overall, the opportunity is aimed at generating the foundational observational evidence needed to make later musculoskeletal, rheumatic, and skin disease clinical studies more feasible, better targeted, and more likely to produce results that are both scientifically solid and meaningful to patients.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clincal Observational (CO) Studies in Musculoskeletal, Rheumatic, and Skin Diseases (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846.
• This funding opportunity was created on 2018-01-29.
• Applicants must submit their applications by 2020-11-03. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $225,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 18 597

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