NIAMS Clinical Trial Implementation Cooperative Agreement

The National Institutes of Health, within the U.S. Department of Health and Human Services, through the National Institute of Arthritis and Musculoskeletal and Skin Diseases, intends to release a Notice of Funding Opportunity to support clinical trial implementation through a cooperative agreement mechanism. NIAMS is a federal research institute focused on advancing knowledge and treatment of arthritis, musculoskeletal, and skin diseases. This funding opportunity reflects the institute’s commitment to supporting high-impact, hypothesis-driven clinical research that can translate into improved patient outcomes and scientific advancement within its mission areas. The purpose of this opportunity is to support investigator-initiated clinical trials that are ready for implementation. Eligible trials may be single-site or multi-site and can span any phase of clinical research, provided that substantial preparatory work has already been completed prior to application. This includes finalized study design, protocol synopsis, and data analysis planning. The program is structured as a cooperative agreement, meaning that NIAMS program staff will have substantial involvement in oversight and coordination throughout the lifecycle of the project. The funding is structured in two phases. The first phase supports final preparatory activities necessary to launch the clinical trial, such as establishing a single Institutional Review Board, finalizing site agreements, executing contracts, and hiring staff. Advancement to the second phase, which supports actual trial implementation, is contingent upon successful completion of predefined milestones established in the initial phase and approved by NIAMS. Projects that meet these milestones will be administratively reviewed and prioritized for transition to full trial execution. Funding is expected to support a limited number of awards, with approximately four awards anticipated. While a minimum funding level is indicated, full funding parameters including ceiling and total program funding have not yet been specified in this forecast notice. There is no cost sharing or matching requirement associated with this program. Funding will support allowable costs directly tied to trial preparation and execution, consistent with NIH cooperative agreement guidelines and federal cost principles. Eligibility for this opportunity is broad and inclusive, encompassing a wide range of domestic and international entities. Eligible applicants include state and local governments, public and private institutions of higher education, nonprofit organizations with or without 501(c)(3) status, for-profit entities including small businesses, tribal governments and organizations, and certain federal agencies. Foreign institutions and U.S. territories may also be eligible, reflecting the global scope of clinical research collaborations supported by NIH. The application process will follow NIH standard submission procedures through Grants.gov and related systems once the full funding announcement is released. While specific application components are not yet detailed, applicants should expect to submit comprehensive research plans, milestone timelines, and documentation demonstrating readiness for trial initiation. The forecast indicates an estimated application due date in early July 2027, with awards expected in April 2028 and project start dates aligned with award issuance. This opportunity is currently in a forecast stage, with an estimated posting date in November 2026. Investigators are encouraged to monitor updates and prepare in advance by ensuring that all preliminary trial design elements are complete. Contact with NIAMS program staff is available via the provided email address for inquiries. This funding opportunity is not explicitly stated as recurring, though similar NIH clinical trial mechanisms are often reissued periodically.