Cooperative Agreement for Clinical Trials in Communication Disorders (U01 – Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for institutions and organizations capable of conducting rigorous clinical trials in communication disorders. Eligible applicants typically include academic medical centers, universities, hospitals, research institutions, and nonprofit research organizations with established research infrastructure. The program supports collaborative, multi-site clinical research investigating interventions, treatments, or diagnostic approaches for speech, language, hearing, and balance disorders. Applicants must have appropriate facilities, qualified personnel, and capacity to conduct good clinical practice (GCP)-compliant research. NIH funding is available to domestic institutions (U.S. states, territories, and possessions) and international collaborations, though foreign applicants may have restrictions. The cooperative agreement mechanism indicates that NIDCD will engage in substantial collaboration with awardees throughout the research period.
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Program description
The NIDCD is committed to identifying effective interventions for the treatment or prevention of communication disorders by supporting well designed and well executed clinical trials. This funding opportunity announcement (FOA) supports a cooperative agreement between an NIDCD Project Scientist and an investigator to support a clinical trial that meets ANY of the following criteria: requires FDA oversight, is intended to formally establish efficacy, or has a higher risk to potentially cause physical or psychological harm.
Who can apply
Eligible applicants
How to apply
Application links
Required documents
- NIH Form SF-424 (R&R) and associated NIH forms (PHS 398)
- Project narrative (research strategy with aims, significance, innovation, approach, and timeline)
- Detailed budget and budget justification
- Biosketches of key personnel (5-page limit)
- Institutional support letters and evidence of commitment
- Clinical trial protocol and statistical analysis plan
- Preliminary data, safety plans, and Data Safety Monitoring Board plans
- Letters of support from collaborating sites (for multi-site trials)
- IRB approval or documentation of IRB review plan
- Regulatory documentation if applicable (FDA pre-IND briefing, etc.)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.173 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$67,501,043
-
$41,811,330
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$29,666,573
-
$25,009,162
-
$22,883,624
-
$22,740,456
-
$16,596,227
-
$13,760,149
-
$12,363,350
-
$12,276,804
Top States by Funding
- MA 11 awards $143.1M
- CA 10 awards $101.6M
- IA 5 awards $77.5M
- CT 2 awards $76.3M
- MD 8 awards $65.0M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.173). How funding has trended year over year.
| 2024 | $422,034,489 | |
| 2025 | $422,700,014 | |
| 2026 est. | $427,030,000 |
FAQ
What types of organizations can apply for this grant?
Academic institutions, research universities, medical centers, hospitals, and 501(c)(3) nonprofit research organizations with documented research capacity are eligible. Organizations must demonstrate adequate infrastructure, qualified staff, and institutional commitment to support clinical trials in communication disorders.
Can individual researchers or small practices apply?
Individual researchers may apply as part of an institution, but the applicant organization must be the entity with legal authority and research capacity. Solo practitioners or small practices typically cannot apply independently.
What makes a competitive application for this U01 grant?
Competitive applications demonstrate: strong preliminary data or scientific rationale, clear clinical trial design following current FDA/ICH guidelines, experienced research team with track record in clinical trials, adequate resources and facilities, diversity in study population, and strong institutional support including IRB infrastructure.
What is the deadline and how often does this grant open?
The next deadline is October 18, 2027, with applications opening January 6, 2025. NIDCD typically releases solicitations on a fixed cycle; check NIH parent announcements for other potential deadlines.
What is the typical funding range for U01 cooperative agreements in communication disorders?
Funding varies based on research scope and site complexity, typically ranging from $200,000 to $500,000+ annually for multi-year projects. Budget should be realistic and justified by the research design.
💡 Tips for applicants
- Start planning now: Clinical trial protocols require extensive preparation including IRB approval, regulatory documentation, and detailed operations manuals. Begin writing 6-8 months before submission.
- Emphasize clinical relevance: Clearly explain how your research addresses a gap in treatment, diagnosis, or understanding of communication disorders. Link your trial to patient outcomes and clinical practice impact.
- Demonstrate trial expertise: Highlight prior experience with clinical trial design, good clinical practice compliance, patient recruitment/retention strategies, and data safety monitoring. Include CVs of key personnel with documented trial leadership.
- Build a strong team: Include biostatisticians, clinical coordinators, regulatory specialists, and outcome assessment experts. For multi-site trials, establish clear leadership and collaboration structures early.
- Plan for diversity and recruitment: Detail your strategy for enrolling diverse populations. Address potential barriers to recruitment and retention, especially for underrepresented groups in communication disorders research.
⚠️ Common mistakes
Applications often fail due to weak or insufficient preliminary data that doesn't adequately support the trial hypothesis. Applicants frequently underestimate the complexity of clinical trial logistics, resulting in unrealistic budgets or timelines. Inadequate attention to regulatory requirements, including FDA interactions, IND applications (if applicable), or international protocols, is a common reason for scoring concerns or resubmission requests.
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