NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 - Clinical Trial Required)

The National Institute on Deafness and Other Communication Disorders (NIDCD) has announced the funding opportunity PAR-25-343, titled *NIDCD Cooperative Agreement for Clinical Trials in Communication Disorders (U01 – Clinical Trial Required)*. This initiative supports investigator-initiated clinical trials aimed at advancing interventions for communication disorders, including those related to hearing, balance, taste, smell, voice, speech, and language. Eligible clinical trials must meet at least one of the following criteria: require FDA oversight, aim to formally establish efficacy (e.g., NIH-defined Phase III clinical trials), involve interventions with higher participant risk, or exceed $700,000 in annual direct costs. The cooperative agreement structure ensures significant involvement from NIDCD staff to guide, monitor, and assist the execution of clinical trials. The goal of this funding opportunity is to address critical gaps in diagnosing, treating, and preventing communication disorders by supporting high-quality, well-implemented clinical trials. Examples include testing pharmacologic, non-pharmacologic, and behavioral interventions, evaluating medical devices, and determining the efficacy of new diagnostic tools. Applications must focus on a single clinical trial and address clear scientific objectives, with a strong emphasis on study design, risk management, and clinical relevance. Projects requiring Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications must include appropriate FDA documentation. Eligible applicants include higher education institutions, nonprofit and for-profit organizations, small businesses, state and local governments, tribal entities, public housing authorities, and faith-based organizations. Non-domestic entities are not eligible, but foreign components of U.S. organizations are allowed. All applicants must be registered in SAM.gov, NATO Commercial and Government Entity (NCAGE, if applicable), eRA Commons, and Grants.gov. Program Directors/Principal Investigators (PDs/PIs) must hold eRA Commons accounts and meet NIH requirements for account registration. Application budgets are not capped but must accurately reflect the project's scope and needs. The maximum project period is five years. Applications must include a detailed research plan, statistical analysis, recruitment and retention plans, safety monitoring, milestones, and a data management and sharing plan. Multi-site trials require a Trial Management Plan, while Phase II, III, or IV trials must include an Independent Data Quality Auditing Plan. Post-trial Transition Plans must address long-term care or follow-up needs for participants. Key submission dates are February 27, 2025; June 18, 2025; October 17, 2025; February 18, 2026; June 18, 2026; October 19, 2026; February 18, 2027; June 18, 2027; and October 18, 2027. Letters of intent are encouraged 30 days before the application deadlines. Applications must be submitted through Grants.gov and tracked via eRA Commons. Evaluation criteria include significance, innovation, approach, investigator expertise, and the adequacy of recruitment, retention, and safety monitoring plans. Proposals will undergo peer review, advisory council review, and administrative evaluation. Awards will be contingent on scientific merit, program relevance, and available funding. Post-award reporting requirements include annual Research Performance Progress Reports (RPPR), financial audits, and compliance with NIH data-sharing policies. Successful applicants will be expected to maintain close collaboration with NIDCD staff, comply with regulatory standards, and ensure data integrity and participant safety. For additional guidance, applicants are strongly encouraged to consult with NIDCD staff at least 10 weeks before submission.