NIAMS Clinical Trial Implementation Cooperative Agreement

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for the Clinical Trial Cooperative Agreement Program within the mission areas of the institute. This Notice of Funding Opportunity (NOFO) solicits cooperative agreement applications for implementation of investigator-initiated, single or multi-site, interventional clinical trials (all trial phases). Investigators who have completed all necessary preparation (e.g., the trial design, protocol synopsis, data analysis plan, etc.) through other means may apply for a NIAMS Cooperative Agreement Clinical Trial. The first phase is designed to allow the investigators to prepare the final aspects needed to start the trial, (e.g., establishing the single IRB (sIRB), contracts and reliance agreements with sites, hiring of staff, etc.). Transition to the second phase to begin the trial is dependent upon completion of the phase 1 milestones proposed by the investigator and approved by NIAMS. Phase 1 projects that meet their milestones will be administratively considered by NIAMS and prioritized for transition to the second phase. NIAMS expects trials to be hypothesis-driven and have the potential for high clinical impact within the research mission of NIAMS.