NIAMS Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) | PAR 18 594

Opportunity Information: Apply for PAR 18 594

The NIAMS Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required), funding opportunity number PAR-18-594, is a National Institutes of Health (NIH) discretionary grant mechanism designed to support the actual conduct and implementation of investigator-initiated interventional clinical trials across all phases. In practical terms, this FOA is aimed at studies that are ready to enroll participants and carry out an intervention (for example, testing a drug, biologic, device, procedure, or behavioral intervention) and that directly align with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) mission areas. NIAMS signals that it is looking for trials that are hypothesis-driven, structured around clear, measurable milestones, and positioned to make a meaningful impact in NIAMS-relevant clinical research.

A key feature of this opportunity is the typical two-part pathway NIAMS expects for clinical trials. Most applicants are generally expected to complete an R34 planning phase first (Part 1), then apply for the U01 implementation award (Part 2). The R34 is commonly used to finish essential pre-trial work such as finalizing the protocol and manual of operations, confirming feasibility and recruitment approaches, solidifying the statistical analysis plan, setting up data management and quality control systems, ensuring regulatory readiness (for example, IRB processes), and generally demonstrating that the trial is executable. At the same time, NIAMS allows flexibility: if a team has already completed all necessary planning and preparation through other funding or established infrastructure, they may apply directly to the U01 without having previously held an R34. The overall message is that NIAMS wants implementation-ready projects, whether the readiness was achieved through the NIAMS planning route or through other credible means.

Because this is a cooperative agreement (U01) rather than a standard research project grant, awardees should expect substantial NIH involvement consistent with the cooperative model. While the investigators retain primary responsibility for designing and running the trial, the NIH (through NIAMS program staff) typically has an active partnership role that can include coordination around agreed-upon milestones, oversight of progress, and other collaborative activities that help ensure the trial stays on track. The FOA explicitly emphasizes milestone-defined trials, which usually means applicants need to propose concrete performance and timeline targets (for example, site activation, recruitment rates, retention targets, data quality indicators, and interim deliverables) and be prepared for continued monitoring against those targets during the award period.

Eligibility is broad and includes many types of domestic organizations and governmental entities. Eligible applicants listed include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; Native American tribal organizations other than federally recognized tribal governments; nonprofits (both 501(c)(3) and non-501(c)(3), excluding higher education institutions when categorized separately); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions. However, it is explicit that non-domestic (non-U.S.) entities (foreign institutions/organizations) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. At the same time, foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning a U.S. applicant organization may include certain foreign collaborations or performance sites if they meet NIH policy definitions and requirements.

From an administrative perspective, the sponsoring agency is the National Institutes of Health, the activity category is Health, and the CFDA number associated with this opportunity is 93.846. The FOA record provided lists an original closing date of 2020-11-03 and a creation date of 2018-01-26. The provided source data does not specify an award ceiling or the expected number of awards, so applicants would normally need to consult the full FOA text and NIAMS guidance for budget expectations, project period norms, and any Institute-specific caps or constraints. Overall, the opportunity is best understood as NIAMS support for well-prepared, high-impact, interventional clinical trials that are ready to move from planning into execution, with a cooperative structure and clear accountability through milestones.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAMS Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)" 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 2018-01-26.
• 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.)
• 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 18 594

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