Early to Definitive Clinical Trials (R61/R33 Clinical Trial Required)
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The National Institutes of Health is forecasting a Notice of Funding Opportunity to solicit applications for early to definitive clinical trials. This initiative seeks proposals testing a wide range of interventions, including drugs, devices, biologics, procedures, and behavioral or social interventions, provided they align with the research missions of the participating NIH Institutes, Centers, and Offices. The funding will utilize a bi-phasic, milestone-driven R61/R33 activity code with a maximum project period of seven years. The R61 phase focuses on planning activities, while the R33 phase supports the actual clinical trial. Although applications are not currently being accepted, this notice serves as an advance alert for investigators with expertise in trial design, implementation, and stakeholder engagement to begin developing collaborations and projects.
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Full Description
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.
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