NHLBI Clinical Trial Pilot Studies (R34)

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Purpose. The National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) invites applications proposing pilot studies to obtain data that is critical for the design of robust clinical trials.This Funding Opportunity Announcement (FOA) should be used to fill gaps in scientific knowledge necessary to develop a competitive full-scale clinical trial.Appropriate pilot studies might demonstrate feasibility of an intervention or an experimental design, estimate intervention parameters, or gather other data important for the design of a 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 to this announcement.Applications must demonstrate that the proposed pilot studies are both necessary and sufficient to permit the design of the clinical trial.During the evaluation of applications in response to this FOA, the review group will also consider the significance and potential public health impact of the full-scale clinical trial that would be proposed following the R34 award period.The NHLBI anticipates that the R34 award period will yield more competitive investigator-initiated clinical trial grant applications and more robust and successful clinical trials that evaluate interventions for the treatment or prevention of heart, lung, blood, or sleep disorders. Mechanism of Support. This FOA will utilize the R34 grant mechanism. Funds Available and Anticipated Number of Awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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