Early to Definitive Clinical Trials (R61/R33 Clinical Trial Required)

Forecasted opportunity (not yet open for applications; expected to be posted around 2027-05-31; estimated application due date 2027-07-31). The National Institutes of Health (NIH) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose early to definitive clinical trials. Trials testing drugs, devices, biologics, procedures, behavioral, social, economic, health services, or other biomedical or non-pharmacological interventions are of interest to this initiative. The trials should align with the research mission of the participating Institutes, Centers, and Offices (ICOs) of the NIH. The NOFO will utilize the R61/R33 activity code, a bi-phasic, milestone-driven award. The R61 phase provides support for planning activities, and the R33 phase provides support for a clinical trial, with a maximum project period of 7 years. Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and relevant projects. Investigators with expertise in clinical trial planning, design, implementation, intervention development, and/or stakeholder engagement are encouraged to consider applying for the NOFO.