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: June 16, 2025 (New) | July 16, 2025 (Renewal/Resubmission/Revision) | September 7, 2025 (AIDS) | October 16, 2025 (New) | November 16, 2025 (Renewal/Resubmission/Revision) | January 7, 2026 (AIDS) | February 16, 2026 (New) | March 16, 2026 (Renewal/Resubmission/Revision) | May 7, 2026 (AIDS) | June 16, 2026 (New) | July 16, 2026 (Renewal/Resubmission/Revision) | September 7, 2026 (AIDS) | October 16, 2026 (New) | November 16, 2026 (Renewal/Resubmission/Revision) | January 7, 2027 (AIDS)
Funding Amounts: Up to $450,000 direct costs over 3 years; no more than $225,000 direct costs in any single year; maximum project period is 3 years.
Summary: Supports pilot studies essential for planning Phase II-IV clinical trials on heart, lung, blood, and sleep disorders within NHLBI’s mission.
Key Information: Updated March 2025; applications must include a 3-page future clinical trial description and comply with new NIH Data Management and Sharing requirements.
Description
This opportunity from the National Heart, Lung, and Blood Institute (NHLBI) supports pilot studies that are both necessary and sufficient to inform the planning of a future Phase II, III, or IV clinical trial. The focus is on research that addresses critical gaps in information needed to finalize the design, protocol, or operational aspects of a subsequent clinical trial within NHLBI’s mission areas: heart, lung, blood, and sleep disorders.
The R34 mechanism is distinct from study start-up or preparation phases; it is intended to generate new, actionable information (scientific or operational) that will directly inform the design and feasibility of a future clinical trial. The results of the R34 pilot study should be sufficient to permit final decisions about the subsequent trial, without the need for further preliminary studies. Regardless of R34 outcomes, a new application is required for the future clinical trial.
