NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)

This Notice of Funding Opportunity Announcement (NOFO) supports studies that are necessary and sufficient to inform the planning of a Phase II-IV clinical trial within the National Heart, Lung, and Blood Institute's (NHLBI) mission. The NHLBI expects that applications to this NOFO will describe the planned clinical trial and demonstrate that the proposed research is scientifically necessary to design or plan the subsequent trial. The planned Phase II, III, or IV trial must be primarily intended to test the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and/or treatment of heart, lung, blood, and sleep disorders. • The R34 mechanism is intended to provide new information that answers a scientific or operational question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial. • The NOFO will support research projects that are designed to provide results that will be sufficient to inform the future trial without further studies. • The opportunity is open to various applicant types, including public housing authorities, independent school districts, small businesses, and nonprofits. • The expected application count is 100, and the application size is not specified.