NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders
National Institutes of Health (NIH)
R61 phase: Up to $250,000 in direct costs per year.
R33 phase: Up to $1,515,000 in direct costs per year.
Maximum project period: 5 years (up to 2 years for R61 and up to 3 years for R33).
To support investigator-initiated Phase I clinical trials for HLBS disorders.
Facilitate the development of new clinical interventions.
Investigators and researchers in the field of HLBS disorders.
Patients suffering from heart, lung, blood, and sleep disorders.
Eligible organization types include higher education institutions, nonprofits, for-profit organizations, small businesses, local governments, state governments, and tribal governments.
Non-domestic (non-U.S.) entities are not eligible to apply, but foreign components of U.S. organizations are allowed.
No specific geographic limitations mentioned, but non-domestic entities are not eligible.
Focus on Phase I clinical trials for HLBS disorders.
Must include activities directly related to the therapeutic/diagnostic in preparation for the clinical trial.
R61 phase budget limited to $250,000 in direct costs per year.
R33 phase budget should not exceed $1,515,000 in direct costs per year.
Application due dates are set for January 3, 2025, and subsequent cycles.
All applications are due by 5:00 PM local time of the applicant organization.
No restrictions on prior grant funding mentioned.
Applications must include a detailed listing of clinical trial research experience.
A Project Management Plan must be provided.
Applications will be evaluated based on significance, innovation, rigor, feasibility, and expertise.
Applications will undergo a peer review process and a second level of review by the appropriate national Advisory Council or Board.
Scientific and technical merit of the proposed project will be a primary consideration.
The grant requires a bi-phasic, milestone-driven approach.
Applications that do not comply with submission guidelines may be delayed or rejected.
Encouragement to consult with NHLBI staff prior to submission for guidance.
Applications that address contingency plans for potential delays are encouraged.
Clear articulation of milestones and adherence to timelines.
Failure to comply with application instructions.
Engage with NHLBI staff early in the application process.
Demonstrate a multidisciplinary team with relevant experience.