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.
More details
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
- Adhere strictly to milestone-driven requirements
- Prepare for a competitive application process
- Verify eligibility criteria carefully
Generated from official source details for readability
Eligibility
Eligible Applicant Types
Additional Criteria
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.
Overview
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.
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
Use of Funds
Funds can be used to support the start-up and implementation of Phase I clinical trials, including final preclinical activities like stability and shipping studies, site training, and other preparatory tasks directly related to the trial.
Cost Sharing
Not Required
Important Dates
- Posted
- Dec 5, 2024
- Deadline
- Jan 7, 2027(208 days)
- Archive Date
- Feb 12, 2027
- Last Updated
- Dec 5, 2024
- Est. Award Date (AI estimate)
- Spring 2027
Application Checklist
- Verify organizational eligibility
- Develop a detailed clinical trial proposal
- Outline preclinical activities and milestones
- Prepare a comprehensive budget
- Gather necessary documentation for IRB approval
- Secure letters of support from collaborators
- Compile research team qualifications
- Ensure compliance with regulatory requirements
- Submit proof of concept data
- Complete all application forms and submit by deadline