Multi-Site Investigator-Initiated Clinical Trials (Collaborative UG3/UH3 Clinical Trial Required)

The National Institutes of Health (NIH) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for investigator-initiated multi-site clinical trials. The proposed trials must be relevant to the research mission of the participating ICs and meet the NIH definition of a clinical trial. The objective of the application is to present a comprehensive scientific and operational plan for the trial, as well as a plan to provide overall project coordination, administration, data management, and biostatistical support for the clinical trial. The key aspects of this opportunity include: • The development and implementation of investigator-initiated multi-site clinical trials • The proposal of a comprehensive scientific and operational plan for the trial • The provision of overall project coordination, administration, data management, and biostatistical support for the clinical trial • The requirement for proposed trials to be relevant to the research mission of the participating ICs and meet the NIH definition of a clinical trial • The use of a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase up to 2 years (UG3) and a full enrollment and clinical trial implementation phase up to 5 years (UH3), for a total award duration of up to 7 years.