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NHLBI Clinical Trial Pilot Studies (R34 Clinical Trial Optional)

US National Institutes of Health – National Heart, Lung, and Blood Institute (NHLBI) grant open #PAR-25-032
Response due Jan 07, 2027 · 00:00 UTC

Summary

The National Heart, Lung, and Blood Institute (NHLBI) is soliciting applications for clinical trial pilot studies under the R34 mechanism. This funding opportunity supports early-phase, small-scale clinical trial pilot or feasibility studies relevant to NHLBI's mission areas (heart, lung, blood, and sleep disorders). The R34 mechanism is designed to allow investigators to gather preliminary data and assess the feasibility of a larger clinical trial before committing full resources. Clinical trials are optional under this announcement, meaning non-trial research may also be submitted.

What they want

Applicants must propose pilot or feasibility studies that lay the groundwork for future full-scale clinical trials addressing conditions within NHLBI's research portfolio (cardiovascular, pulmonary, hematologic, and sleep-related diseases). Studies may or may not include a clinical trial component. Funded projects are expected to generate data on feasibility, recruitment, protocol tolerability, and preliminary efficacy to support subsequent larger trials.
Deliverables
  • Pilot/feasibility study protocol
  • Recruitment and retention data
  • Preliminary safety and efficacy data
  • Feasibility assessment report
  • Progress and final reports to NIH
Technical requirements
  • Research must align with NHLBI mission areas (heart, lung, blood, sleep disorders)
  • R34 mechanism application format required
  • Clinical trial component is optional but must be declared at time of application
  • Must demonstrate path toward a larger-scale clinical trial

How they evaluate

  • Scientific and technical merit (peer review by NIH study section)
  • Significance and innovation
  • Investigator qualifications
  • Approach and feasibility
  • Environment and institutional support
Submission: Grants.gov electronic submission (PAR-25-032)

Eligibility & certifications

SAM registration (System for Award Management)Institutional assurances (IRB, Human Subjects protections as applicable)NIH registration in eRA Commons

Risks & flags

  • No dollar values or award ceiling stated — budget guidance must be confirmed in full FOA text
  • Multi-year open window (Dec 2024 – Jan 2027) with multiple submission cycles likely — exact due dates per cycle not extractable from synopsis alone

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

NHLBI Clinical Trial Pilot Studies (R34 Cl…
Due Jan 07
Onboard ↗