NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)
Supporting essential pilot studies for NHLBI clinical trials, aiming to inform Phase II-IV trial planning for heart, lung, blood, and sleep disorders.
Funder: National Institutes of Health
Due Dates: November 16, 2026 (Resubmission/revision) | January 7, 2027 (Original closing date) | February 16, 2027 (New applications) | March 16, 2027 (Resubmission/revision; current closing date)
Funding Amounts: Up to $450,000 in direct costs over 3 years, with up to $225,000 in any year
Summary: Supports pilot research necessary and sufficient to finalize planning for a future Phase II–IV trial addressing heart, lung, blood, or sleep disorders.
Key Information: A Future Clinical Trial Description attachment is required; the subsequent trial requires a separate funding application.
Description
The National Heart, Lung, and Blood Institute (NHLBI) supports R34 pilot studies that resolve critical scientific or operational information gaps before a future Phase II, III, or IV clinical trial. The planned trial must test efficacy, safety, clinical management, or implementation of interventions to prevent or treat heart, lung, blood, or sleep disorders. Pilot results must be both necessary and sufficient to inform final trial-design decisions without further studies.
Supported work may refine study populations, consent procedures, statistical methods, interventions, or outcomes; verify recruitment, attrition, event, or response rates; or test adherence and field feasibility. Projects may also standardize interventions across sites, validate surveys, test training tools, or adapt interventions for culturally different populations. Applications may propose a clinical trial or research that is not a clinical trial.
