Atom | NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)

Funder: National Institutes of Health

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.

Due Dates

Standard Due Dates (New Applications): June 16, 2025 | October 16, 2025 | February 16, 2026 | June 16, 2026 | October 16, 2026
Renewal/Resubmission/Revision: July 16, 2025 | November 16, 2025 | March 16, 2026 | July 16, 2026 | November 16, 2026
AIDS-Related Applications: September 7, 2025 | January 7, 2026 | May 7, 2026 | September 7, 2026 | January 7, 2027
Letter of Intent: 30 days before application due date
Expiration Date: January 8, 2027

All applications are due by 5:00 PM local time of the applicant organization.

Funding Amount

Direct Costs: Up to $450,000 over a three-year period
Annual Limit: No more than $225,000 in direct costs in any single year
Project Period: Maximum of 3 years
Number of Awards: Contingent on NIH appropriations and the number of meritorious applications

Eligibility

Eligible applicants include:

Public/State and Private Institutions of Higher Education
Nonprofits with or without 501(c)(3) status (excluding higher education institutions)
For-profit organizations (including small businesses)
State, county, city, township, and special district governments
Independent school districts
Native American tribal governments (federally recognized and other)
Public housing authorities/Indian housing authorities
Faith-based and community-based organizations
Regional organizations
U.S. territories and possessions
Eligible agencies of the federal government

Notes:

Non-domestic (non-U.S.) entities are not eligible to apply.
Non-domestic components of U.S. organizations are eligible.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Application Process

Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
Required Registrations: SAM, eRA Commons, Grants.gov (allow at least 6 weeks for completion).
Letter of Intent: Strongly encouraged, due 30 days before the application deadline.
Application Instructions: Follow the NIH How to Apply - Application Guide and the specific instructions in the funding announcement.
Key Attachments:
- Future Clinical Trial Description (max 3 pages; required)
- FDA Approval Documentation (if applicable)
- Data Management and Sharing Plan (required for all applications generating scientific data)
Budget: Use the R&R Budget Form (not modular); detailed justification required.

Additional Information

Scope: The R34 is not intended for first-in-human studies, protocol writing, infrastructure development, or implementation of already fully designed trials. Purely mechanistic or animal studies are not appropriate.
FDA-Regulated Products: If the pilot involves an FDA-regulated product, IND/IDE authorization must be secured and documented before funding.
Data Management: All applications must include a Data Management and Sharing Plan per the 2023 NIH policy.
Review Criteria: Significance, innovation, rigor, feasibility, investigator expertise, and environment. See the full review criteria.
Clinical Trial Registration: If the pilot study is a clinical trial, registration and results reporting in ClinicalTrials.gov are required.

External Links

Contact Information

Area	Name / Division	Email	Phone
General Grants Info	NIH Grants Information	GrantsInfo@nih.gov	301-480-7075
Application Submission	eRA Service Desk	Online Help	301-402-7469 / 866-504-9552
Grants.gov Support	Grants.gov Customer Support	support@grants.gov	800-518-4726
Cardiovascular Sciences	Patrice Desvigne-Nickens, MD	desvignp@mail.nih.gov	301-435-0504
Blood Diseases & Resources	Andrei L. Kindzelski, MD, PhD	kindzelskial@nhlbi.nih.gov	301-435-0070
Lung Diseases	Michelle Freemer, MD	michelle.freemer@nih.gov	301-435-0202
Translational & Implementation Sciences	Cara Lewis, PhD	cara.lewis@nih.gov	301-569-3076
Peer Review	Director, Office of Scientific Review	nhlbichiefreviewbranch@nhlbi.nih.gov
Financial/Grants Management	Laurel Kennedy	laurel.kennedy@nih.gov	301-827-4777

NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)