PAR-25-026
NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R61/R33 Clinical Trial Required)
Summary
NHLBI Early Phase Clinical Trials for Therapeutics and Diagnostics for HLBS Disorders
Research Focus
This program supports investigator-initiated Phase 0 and Phase I clinical trials for therapeutic and diagnostic interventions targeting heart, lung, blood, and sleep (HLBS) disorders in adults and children. The NHLBI seeks to advance early translational research by funding trials of drugs, devices, biologics (including cells and cell products), and diagnostic tools that address unmet medical needs in HLBS disease. Research contributions include generating safety and feasibility data, establishing dose-response relationships, characterizing pharmacokinetics, and developing functional biological signature measures and clinical outcome measures suitable for larger efficacy trials. The program emphasizes bridging studies that extend existing data from approved populations (e.g., adults) to new populations (e.g., pediatric subjects).
At-a-Glance
- Who can apply: Investigators proposing NIH-defined clinical trials; early contact with NHLBI program staff (≥12 weeks before submission) is encouraged.
- Funding & project length: R61 phase up to $250,000 direct costs/year for up to 2 years; R33 phase budget not stated. Bi-phasic award with milestone-driven transition.
- Award mechanism: R61/R33 exploratory/developmental phased grant; clinical trial required.
- Key dates: Applications due May 7, 2025 (earliest); January 8, 2027 (expiration). Earliest start date December 2025.
- Best fit for: Translational researchers in cardiology, pulmonology, hematology, sleep medicine, and related fields developing early-stage clinical interventions with clear regulatory pathways (IND/IDE) and defined enrollment milestones.
Note: Award budget for R33 phase, total project period duration, and specific HLBS research priorities are not stated in the provided text. Applicants should consult the full NOFO and NHLBI website for additional details on strategic priorities and contact program staff early.
Key Facts
Deadline
Thu, January 7, 2027
Posted
Thu, December 5, 2024
Award / Year (direct costs)
$250,000
Max Total
$500,000
Max Duration
2 years
Keywords
Research Areas
Gotchas (5)
Transition from R61 to R33 phase is contingent on administrative review of milestone completion and is subject to NHLBI funding availability. This creates uncertainty about whether a successful R61 wi
90%
Source Text
“An administrative review of the extent to which peer-reviewed milestones are met in the R61 phase will determine whether the R33 phase award will be issued, subject to NHLBI funding availability.”
R61 phase explicitly prohibits animal studies. If animal studies are needed for trial preparation, applicants must apply separately to Catalyze grants or Catalyze preclinical services, not this NOFO.
90%
Source Text
“Submissions containing animal studies are not permitted for this NOFO. If the project needs additional animal studies or any other activities that are not covered under this NOFO to be ready for the early phase clinical trial, applicants are encouraged to apply for Catalyze grants or Catalyze preclinical services.”
R61 phase budget is capped at $250,000 direct costs per year, but R33 phase budget is not specified in the provided text. Applicants need to verify the R33 budget cap to avoid proposing an unallowable
75%
Source Text
“Application budgets in the R61 phase are limited to $250,000 in direct costs per year.”
Milestone completion and enrollment performance data must be regularly shared through NHLBI's eConnect platform and clinical dashboard database. This is a specific post-award reporting requirement tha
85%
Source Text
“It is expected that performance of core milestones, such as planned enrollment goals, will be shared on a regular basis through eConnect, an NHLBI platform that facilitates transfer of electronic information to NHLBI... It is expected that the performance of critical milestones such as expected enrollment goals will be shared on a regular basis through an NHLBI clinical dashboard database.”
Early contact with NHLBI program officer is strongly encouraged at least 12 weeks prior to submission. This is an unusually long pre-submission consultation window and suggests the mechanism is comple
80%
Source Text
“Investigators are strongly encouraged to consult with the Scientific/Research Contacts listed in Section VII for the area of science for which they are planning to develop an application prior to submitting an application. Early contact (at least 12 weeks prior to submission) is encouraged.”