NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)

Background
The National Heart, Lung, and Blood Institute (NHLBI) is offering a funding opportunity to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite.

Grant Details
The objective of this funding opportunity is to support the implementation of Phase I investigator-initiated single or multi-site clinical trials for diagnostic and/or therapeutic interventions for HLBS disorders. The trials are expected to contribute to the evidence base for important health matters relevant to the research mission of NHLBI. The NOFO will utilize a milestone-driven R33 mechanism, with a maximum award period of three years. Applicants must address objectives for the R33 mechanism and are strongly encouraged to use project management principles to help facilitate achievement of performance milestones as appropriate.

The R33 phase may include further testing of the intervention's feasibility, safety, and acceptability; determining the optimal dose for a subsequent trial; determining the pharmacokinetics of the dose and formulation of the product; and developing functional biological signature measures and clinical outcome measures feasible for use in larger efficacy and effectiveness trials.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state and local governments, federal agencies, U.S. territories or possessions, independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), faith-based or community-based organizations, and regional organizations. Foreign organizations are not eligible to apply.

Period of Performance
The project period starts from June 4, 2024, with an earliest start date in September 2024. The maximum period is 3 years.

Grant Value
Application budgets should not exceed $1,515,000 in direct costs per year. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.