The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), has announced the funding opportunity PAR-25-032, titled "NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)." This opportunity supports studies necessary and sufficient to inform the planning of a Phase II-IV clinical trial within NHLBI’s mission areas. The aim is to address scientific and operational questions required to refine and finalize the design of future trials focused on the prevention and treatment of heart, lung, blood, or sleep disorders. These R34 studies are expected to yield actionable results without the need for further preliminary studies before the main trial can be conducted.

The funding opportunity emphasizes that proposed studies must fill critical gaps in knowledge regarding study populations, interventions, or operational risks. Research topics may include refining study populations, standardizing interventions or outcomes, verifying attrition or response rates, and testing feasibility of interventions. Projects requiring U.S. Food and Drug Administration (FDA) approval must secure appropriate authorizations and provide supporting documentation before a funding decision will be made. Applications focused on mechanistic studies, infrastructure development, or purely protocol-writing exercises will not be considered.

Eligible applicants include public and private institutions of higher education, state and local governments, nonprofits with or without 501(c)(3) IRS status, for-profit organizations, small businesses, and tribal governments and organizations. Foreign organizations are not eligible to apply, but non-domestic components of U.S. organizations are allowed. Applicants must ensure all required registrations, including System for Award Management (SAM), eRA Commons, and Grants.gov, are completed in advance.

Applicants may request up to $450,000 in direct costs over a three-year period, with a maximum of $225,000 in any single year. Applications are due on standard NIH submission dates starting February 16, 2025, with additional due dates in June and October each year until the expiration date on January 8, 2027. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP), which will be reviewed for its contribution to the scientific and technical merit of the project. The PEDP must outline actionable strategies for inclusivity and diversity throughout the research process.

Proposals will be evaluated based on scientific significance, innovation, feasibility, investigator expertise, and institutional resources. Additional review criteria include human subject protections, data safety monitoring plans, and adherence to NIH policies on data management and sharing. Final funding decisions will consider scientific merit, program priorities, and availability of funds.

Applications must be submitted electronically through ASSIST, Grants.gov Workspace, or an institutional system-to-system platform. NIH encourages early submission to address any potential technical errors during the submission process. For further details, applicants are encouraged to contact program staff at NHLBI or consult the application guide and NIH policy notices relevant to this opportunity.