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.

Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...