Notice of Intent to Publish a Funding Opportunity Announcement for NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)

Key Dates

None

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) intend to publish a Notice of Funding Opportunity (NOFO) to solicit applications for large single or multisite clinical trials within the mission area of the institute.

The NOFO is expected to be published in Spring 2024 with an expected application due date in Summer 2024.

Only New, Resubmission and Revision applications will be eligible.

This NOFO will utilize the UG3/UH3 phased cooperative agreement activity code. A UG3 milestone plan is required.

Details of the planned NOFO are provided below.

This Notice encourages investigators to prepare to apply for large clinical trial implementation cooperative agreements within the NIAMS mission areas. The phased award design will permit a 1-year, milestone-driven planning phase (UG3) where the investigative team can prepare the necessary documents, reliance agreements, establish the single IRB, etc. needed for transition to begin the trial in the UH3 phase. The UH3 phase can be up to 5-years in duration.

Different from previous NIAMS clinical trial solicitations, investigators will need to have previously completed all necessary preparation (activities normally achieved by a planning grant or funded by other means that include the development of the final protocol, the statistical analysis plan, manual of operating procedures, consent/assent forms, FDA regulatory submissions, etc.) that are often necessary prior to implementing a clinical trial.

Examples of studies that might be supported by this new NOFO include, but are not limited to:

• Clinical trials focusing on the prevention or treatment of a rheumatic, musculoskeletal or skin disease or disorder;
• Clinical trials to investigate safety, efficacy, or effectiveness of novel therapeutic approaches for a rheumatic, musculoskeletal or skin disease or disorder;
• Clinical trials testing methods to increase preventive health behaviors for a rheumatic, musculoskeletal or skin disease or disorder.

Communication with a NIAMS program director is highly recommended prior to submission.

Funding Information

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government

Applications are not being solicited at this time. 

Inquiries

Charles Washabaugh, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Phone: 301-496-9568
Email:charles.washabaugh@nih.gov