NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required)
NIDCD funds clinical trials on communication disorders with FDA oversight, focus on efficacy, or high risk impact to treat or prevent such disorders.
Funder: National Institutes of Health
Due Dates: June 18, 2025 | October 17, 2025 | February 18, 2026 | June 18, 2026 | October 19, 2026 | February 18, 2027 | June 18, 2027 | October 18, 2027
Funding Amounts: No budget cap; budgets must reflect actual project needs. Maximum project period: 5 years. Direct costs ≥$500,000/year require prior approval.
Summary: Supports investigator-initiated clinical trials in communication disorders (hearing, balance, smell, taste, voice, speech, language) that require FDA oversight, aim to establish efficacy, or pose higher participant risk.
Key Information: Only one clinical trial per application; multi-site trials require a trial management plan; prior consultation with NIDCD staff is strongly encouraged.
Description
This opportunity, offered by the National Institute on Deafness and Other Communication Disorders (NIDCD) at NIH, funds investigator-initiated clinical trials focused on communication disorders, including hearing, balance, smell, taste, voice, speech, and language. The program uses the U01 cooperative agreement mechanism, which involves substantial NIH programmatic involvement throughout the project.
The funding is specifically for clinical trials that:
- Require FDA oversight (e.g., IND or IDE applications),
- Are intended to formally establish efficacy (such as pivotal/Phase III trials),
- Or involve higher risk to participants (e.g., non-routine interventions, unlicensed products/devices, or licensed products/devices for unapproved indications).
The goal is to advance interventions into standard clinical care through well-designed and well-implemented clinical trials. Only one clinical trial may be proposed per application.
