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This Funding Opportunity Announcement (FOA) is to support studies that are essential, yet also sufficient, for investigators to make definitive decisions about the designs of important clinical trials within NHLBI's mission, 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 pilot studies are both necessary and sufficient to permit definitive decisions about the design of the subsequent clinical trial. Applicants who propose solely to write a protocol or manual of operations or to develop infrastructure for a clinical trial will not be considered appropriate for this announcement. The NHLBI anticipates that the R34 award period will yield robust investigator-initiated clinical trial grant applications for the evaluation of interventions for the treatment or prevention of heart, lung, blood, or sleep disorders.
Read the full FOA: PAR-18-463