Grant Details

GRANT OVERVIEW

Grant Name and Funding Organization

NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders

National Institutes of Health (NIH)

Total Funding Amount and Duration

No specific ceiling on application budgets, but must reflect actual project needs.

Maximum project period is 5 years.

Primary Objective and Mission Statement

To identify effective interventions for the treatment or prevention of communication disorders.

Support well-designed and executed clinical trials.

Key Stakeholders and Beneficiaries

Individuals with communication disorders.

Researchers and institutions involved in clinical trials.

ELIGIBILITY CRITERIA

Organization Requirements

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

Non-domestic (non-U.S.) entities are not eligible to apply.

Geographic Scope

U.S. based organizations are eligible; non-domestic components of U.S. organizations are not eligible.

Project Requirements

Clinical trials must require FDA oversight, aim to establish efficacy, or present higher risks.

Only one clinical trial may be proposed per application.

Financial Requirements

Applications exceeding annual direct costs of $700,000 may be considered.

No cost-sharing is required.

Timeline Requirements

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

Open date for submission is January 27, 2025, with a response date of October 18, 2027.

Previous Funding Considerations

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

APPLICATION PROCESS

Required Documentation and Materials

Applications must follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.

Evaluation Criteria and Scoring System

Applications will be evaluated based on scientific and technical merit, including significance, innovation, rigor, and feasibility.

Review Process and Timeline

Applications will undergo peer review and may be discussed in a selection process.

Selection Criteria and Priorities

Scientific merit and relevance to program priorities will be key in funding decisions.

SPECIAL CONSIDERATIONS

Unique Aspects or Requirements

Substantial NIH programmatic involvement is anticipated during the project.

Potential Challenges or Limitations

Applications that include more than one clinical trial will not be supported.

Strategic Alignment Opportunities

Investigators are encouraged to contact NIH staff prior to submission for guidance.

Competitive Advantages or Disadvantages

Strong emphasis on community engagement and recruitment strategies in applications.

KEY INSIGHTS AND RECOMMENDATIONS

Critical Success Factors

Well-defined project milestones and a clear data management plan are essential.

Common Pitfalls to Avoid

Ensure compliance with all application instructions to avoid delays or rejection.

Strategic Recommendations for Applicants

Engage with community partners to enhance recruitment and retention plans.

Competitive Positioning Advice

Highlight the innovative aspects of the proposed clinical trial to stand out.

Grant Details

clinical trials communication disorders healthcare research NIH funding FDA oversight intervention public health
NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required)
PAR-25-343
NIH Grants
EDU NGO PUBLIC ENTERPRISE SME OTHER
US
RESEARCH_DEVELOPMENT
False
None
None
None
USD
None
True
True
To advance interventions into standard clinical care for communication disorders.
Completion of clinical trial and submission of results to ClinicalTrials.gov.
Oct. 18, 2027, 10 p.m.
March 2025 - October 2027
Follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide.
True
Peer review based on scientific and technical merit.
Significance and innovation of the proposed research.
Rigor and feasibility of the proposed approach.
Potential impact on the field of communication disorders.
True
True
Cooperative Agreement
Compliance with NIH Grants Policy Statement and specific terms of award.
Annual reporting and submission of final RPPR.
Funds provided on a capitation basis as per approved budgets.
Compliance with federal regulations and NIH policies.
Specific to health and clinical research sectors.