The NIAMS is committed to improving the health of patients with rheumatic, musculoskeletal, and skin diseases by supporting investigator-initiated clinical trials. The NIAMS’s goal is to identify and support trials that are timely and informative, and that will lead to improvements in clinical practices for disease prevention, diagnosis, and treatment.

The NIAMS supports investigator-initiated, clinical interventional trials through a Clinical Trial Implementation Cooperative Agreement (U01) that supports the complete implementation and conduct of the study. These studies are often complex, involve a large number of subjects or are higher risk, and we strongly recommend speaking with a NIAMS Program Officer prior to submission of an application. These larger and more complex trials require substantial planning and preparation prior to opening for recruitment. Investigators are encouraged to apply for a NIAMS Clinical Trial Planning Grant (R34) before applying for the U01 to implement the trial.

Investigators who are considering applying for a Clinical Trial Implementation Cooperative Agreement with a budget of $500,000 or more in direct costs in any year must consult with the NIAMS ahead of time to ensure the Institute will accept an application, as per NIH policy. Procedures for how a principal investigator (PI) requests an LOR can be found at https://www.niams.nih.gov/grants-funding/applying-grant/niams-large-grant-policy. Please see the Milestone Checklist for LOR due dates.

Note that the NIAMS may require up to 10 weeks when making a decision as to whether to accept a U01 application with a budget of $500,000 or more in direct costs. Please consider this when constructing the grant application submission timeline. The NIAMS will inform the applicant by email of the decision.

If you have questions about this policy as it relates to clinical trials, please contact: NIAMSclinicaltrials@mail.nih.gov.