NIDCD Seeks Input on Clinical Trial Support

Request for Information (RFI): Seeking Input on the NIDCD Support of Clinical Trials Notice Number: NOT-DC-26-026

Key Dates

Release Date: March 17, 2026 Response Date: April 15, 2026

Related Announcements

None

Issued by

National Institute on Deafness and Other Communication Disorders (NIDCD)

Purpose

The National Institute on Deafness and Other Communication Disorders (NIDCD) is seeking input from interested parties to address strengthening NIDCD clinical trial infrastructure and support.

Background

NIDCD is committed to the development of therapies and interventions to treat and prevent communication and other disorders in our core mission areas: hearing, balance, taste, smell, voice, speech, and language.

The NIDCD actively supports a portfolio of R01 and U01 clinical trials across the seven mission areas of NIDCD focused on advancing interventions across devices, drugs, behavioral strategies, and nutritional approaches. These trials have been strategically managed by a dedicated Clinical Trials Section composed of medical officers, trial experts, statisticians, and operational support staff. The goal of the NIDCD Clinical Trials Section is to ensure appropriate stewardship for NIDCD clinical trials. NIDCD has convened a workgroup of the National Deafness and Other Communication Disorders (NDCD) Advisory Committee to examine how NIDCD can best grow, support and manage clinical trials. A key focus of the NIDCD clinical trials effort is to support the conduct of well-designed, rigorous, high-impact pivotal Phase II studies that lay the foundation for successful Phase III trials, ultimately accelerating the translation of research findings into effective patient care practices and maximizing the impact of federal investment in clinical research.

Information Requested

The NIDCD is seeking input to guide the NDCD Clinical Trials Workgroup on the capabilities and growth of the NIDCD clinical trials program, aimed at advancing therapies and timely interventions for disorders related to hearing, balance, taste, smell, voice, speech, and language. We invite interested parties to share their perspectives on how NIDCD can best support translation of scientific discoveries into effective and accessible treatments and clinical trials that improve the lives of people with communication disorders spanning hearing, balance, taste, smell, voice, speech, and language.

Responses are welcomed on any or all of, but not limited to, the topics below:

1. Leveraging NIDCD and NIH resources to better support the translation of scientific discoveries into effective clinical trials and patient therapies
2. Institutional resources and infrastructure needed to enable investigators to successfully plan and implement rigorous high-quality clinical trials in NIDCD mission areas
3. Challenges to the development and successful submission of a clinical trial application to NIDCD
4. Clinical trial milestone(s) most difficult to achieve and what could be helpful in addressing this issue
5. Capacity building training and mentoring to assist the next generation of NIDCD clinical scientists to achieve success How to Submit a Response

All comments must be submitted electronically via email to [email protected]

Responses must be received by 11:59:59 pm (ET) on April 15, 2026

Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable information or any information that you do not wish to make public. Proprietary, classified, confidential, or sensitive information should not be included in your response. NIH will use the information submitted in response to this RFI at its discretion. NIH reserves the right to use any submitted information on public websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements. This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.

We look forward to your input and hope that you will share this RFI opportunity with your colleagues.

Inquiries

Please direct all inquiries to:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Email: [email protected]

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