This grant is designed to support early-stage clinical trials that focus on developing new treatments or diagnostic tools for heart, lung, blood, and sleep disorders. It helps researchers get their trials off the ground by funding necessary pre-trial activities and the initial phases of the trial itself. The grant is structured in two phases, where the first phase supports final preparations before the trial begins.
Who it's for: This grant is for researchers and organizations interested in conducting Phase I clinical trials for new treatments or diagnostics related to heart, lung, blood, and sleep disorders. Eligible applicants include small businesses, nonprofits, educational institutions, tribal governments, and various levels of government.
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Likely Disqualifiers
- Proposals not related to HLBS disorders
- Lack of a clear clinical trial plan
- Ineligible organization type
- Incomplete application
- Failure to meet preclinical requirements
What You May Need
- Detailed clinical trial proposal
- Preclinical activity plan
- Milestone-driven project timeline
- Budget justification
- Organizational eligibility documentation
- Research team qualifications
- Regulatory compliance plans
- Letters of support or collaboration
- Proof of concept data
- Institutional Review Board (IRB) approval
Cautions
- Ensure all activities in the R61 phase are directly related to the trial