NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)

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This Funding Opportunity Announcement (FOA) is to support studies that are scientifically essential, yet also sufficient, for investigators to make definitive decisions that inform the final designs of important Phase II and beyondclinical trials within NHLBI's mission; that is, clinical trials with the primary intent of testing the efficacy, safety, clinical management, or implementation of intervention(s) in the prevention and treatment of heart, lung, blood, and sleep disorders. This mechanism may be used to test the feasibility of novel and efficient (pragmatic) trial designs, as well as determine the feasibility of an intervention, intervention parameters, subject availability, or other information essential to complete the design of a trial. Applications should demonstrate that the proposed studies are both necessary and sufficient to permit definitive decisions about the final design of the subsequent clinical trial. Applicants who propose solely to write a protocol or manual of operations,to develop infrastructure for a clinical trial, or implement a fully designed trialwill not be considered appropriate for this announcement. Please note that NHLBI supports other funding opportunities for clinical trials-see https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/clinical-trials-optimization for information on other NHLBI clinical trial funding opportunity announcements. In contrast to the planning or study start up phase of other NHLBI clinical trial FOAs, the R34 mechanism is intended to provide new i?n?f?o?r?m?a?t?i?o?n that answers a scientific question(s) which may be pragmatic in nature and, therefore, informs the final development of a Phase II-IV clinical trial.

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