PAR-25-141
NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
Summary
NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3)
Research Focus
This funding opportunity supports investigator-initiated, single or multi-site interventional clinical trials across all phases targeting arthritis, musculoskeletal, and skin diseases and disorders. NIAMS seeks hypothesis-driven trials with high clinical impact potential that test promising new interventions to improve health outcomes and inform clinical care. Applicants must have completed all prior planning and preparation (trial design, protocol, data analysis plan) before applying; the UG3 phase (up to 1 year) funds final pre-launch activities such as establishing single Institutional Review Board (sIRB) approval, finalizing site contracts and reliance agreements, developing case report forms and data management systems, and obtaining Data and Safety Monitoring Board approval. Successful UG3 completion triggers transition to the UH3 phase for full enrollment and trial execution. The program emphasizes milestone-driven, objective performance metrics, contingency planning, and engagement of people with lived experience (patients, caregivers, advocates) to enhance meaningful outcomes and health equity.
At a Glance
- Who can apply: Investigators with completed trial preparation; single or multi-site interventional trials in NIAMS disease areas (arthritis, musculoskeletal, skin diseases).
- Funding & project length: UG3 phase up to 1 year (milestone-driven); UH3 phase duration not specified. Amounts not stated.
- Award mechanism: UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement.
- Key dates: Open February 4, 2025; multiple rolling due dates through November 2, 2026; earliest start December 2025 (varies by cycle).
- Best fit for: Clinical trialists in rheumatology, orthopedics, dermatology, and musculoskeletal medicine ready to launch enrollment with adaptive or innovative trial designs and robust data management infrastructure.
Key Facts
Deadline
Thu, March 4, 2027
Posted
Mon, December 9, 2024
Award / Year (direct costs)
$500,000
Max Total
$2,500,000
Max Duration
5 years
Keywords
Research Areas
Gotchas (3)
UG3 phase is explicitly NOT designed for collection of preliminary data about intervention efficacy/effectiveness or prospective data to support trial rationale - applicants who plan preliminary studi
95%
Source Text
“The UG3 award supports the planning period and is not designed for the collection of preliminary data (neither clinical nor pre-clinical studies) about the efficacy or effectiveness of an intervention, or the collection of prospective data to support the rationale for a clinical trial.”
Majority of UG3 milestones must be completed 2 months BEFORE transition application deadline (not at end of UG3), creating a compressed timeline that differs from typical milestone-at-end-of-phase str
92%
Source Text
“Investigators will be asked to submit their UH3 phase transition application 2 months prior to transition, so the majority of UG3 phase milestones should be completed 2 months prior to transition to the UH3 phase. All milestones must be achieved prior to transition to the UH3 phase.”
Failure to meet recruitment milestones can result in NIAMS ending support and negotiating phase-out, not just delayed transition - this is a termination trigger
93%
Source Text
“If, at any time, recruitment falls significantly below the projected milestones for recruitment, NIAMS will consider ending support and negotiating an orderly phase-out of the award and retains, as an option, periodic external peer review of progress.”