Grant Details

GRANT OVERVIEW

Grant Name and Funding Organization

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

National Institutes of Health (NIH)

Total Funding Amount and Duration

Maximum budget of $1,515,000 in direct costs per year

Project duration of up to 3 years

Primary Objective and Mission Statement

To support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for HLBS disorders in adults and children.

Key Stakeholders and Beneficiaries

Investigators conducting clinical trials

Patients with heart, lung, blood, and sleep disorders

ELIGIBILITY CRITERIA

Organization Requirements

Eligible organization types include higher education institutions, nonprofits, for-profit organizations, small businesses, local, state, and federal governments.

Specific qualifications include having the necessary skills, knowledge, and resources to carry out the proposed research.

Geographic Scope

U.S. organizations can apply; non-domestic (non-U.S.) entities are not eligible to apply.

Non-domestic components of U.S. organizations are eligible.

Project Requirements

Projects must be phase I clinical trials for HLBS disorders.

Trials can be single or multi-site.

Financial Requirements

Application budgets should not exceed $1,515,000 in direct costs per year.

Cost sharing is not required.

Timeline Requirements

Applications are due by 5:00 PM local time of the applicant organization.

The earliest submission date is January 3, 2025, and the expiration date is January 8, 2027.

Previous Funding Considerations

Applicants may submit more than one application, provided each is scientifically distinct.

The NIH will not accept duplicate or overlapping applications.

APPLICATION PROCESS

Required Documentation and Materials

Applications must include a detailed listing of clinical trial research experience and a project management plan.

Evaluation Criteria and Scoring System

Applications will be evaluated based on significance, innovation, rigor, and feasibility.

Review Process and Timeline

Applications will undergo peer review and be evaluated for scientific and technical merit.

Selection Criteria and Priorities

Funding decisions will consider scientific merit, availability of funds, and relevance to program priorities.

SPECIAL CONSIDERATIONS

Unique Aspects or Requirements

Applicants must be ready to initiate the clinical trial within the first quarter of the project period.

Potential Challenges or Limitations

Applications that do not comply with submission instructions may be delayed or not accepted.

Strategic Alignment Opportunities

Investigators are encouraged to consult with NHLBI staff prior to submission.

Competitive Advantages or Disadvantages

The grant emphasizes milestone-driven funding, which may provide a structured approach to project management.

KEY INSIGHTS AND RECOMMENDATIONS

Critical Success Factors

Meeting defined milestones is crucial for continued funding.

Common Pitfalls to Avoid

Ensure compliance with all application instructions to avoid delays.

Strategic Recommendations for Applicants

Engage with NHLBI staff early in the application process.

Competitive Positioning Advice

Highlight the significance and innovation of the proposed clinical trial in the application.

Grant Details

clinical trials healthcare therapeutics diagnostics heart disorders lung disorders blood disorders sleep disorders NIH funding R33 grants
NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics for HLBS Disorders (R33 CT Required)
PAR-25-025
NIH Grants
EDU NGO ENTERPRISE PUBLIC SME OTHER
US
RESEARCH_DEVELOPMENT
False
1515000.00
None
1515000.00
USD
None
True
False
The grant aims to facilitate the development of new clinical interventions for HLBS disorders, addressing unmet medical needs.
Successful completion of clinical trials and achievement of defined milestones.
Jan. 7, 2027, 10 p.m.
Not specified
Clinical Trial Research Experience and Project Management Plan.
True
Applications will be evaluated based on significance, innovation, rigor, and feasibility.
Applications must demonstrate innovative approaches to clinical trials.
Applications must outline a feasible plan for conducting the clinical trial.
Applications must address significant health issues related to HLBS disorders.
True
True
Grant
Recipients must comply with all NIH policies and reporting requirements.
Annual reporting on progress and financial statements.
Payments will be made according to NIH policies.
All NIH awards are subject to the terms and conditions outlined in the NIH Grants Policy Statement.
No additional sector-specific requirements.