NIDCD Phase I/II Preliminary Clinical Trials in Communication Disorders (R01) | Apply Online

Frequently Asked Questions (FAQs)

What agency is offering this grant opportunity?

This opportunity was offered by the National Institute on Deafness and Other Communication Disorders (NIDCD), which is part of the National Institutes of Health (NIH).

What is the main purpose of this funding opportunity?

The purpose is to fund Phase I and Phase II preliminary clinical trials focused on improving the treatment or prevention of communication disorders. The program is designed to strengthen the clinical evidence pipeline by supporting early-stage trials that resolve key scientific and operational questions before a team commits to a larger, more expensive Phase III definitive clinical trial.

What types of studies are supported under this announcement?

The announcement supports Phase I/II Preliminary Clinical Trials (PCTs) intended to generate preliminary data needed to plan a future Phase III Definitive Clinical Trial (DCT).

What is a Phase I/II Preliminary Clinical Trial (PCT) in the context of this program?

In this program, a Phase I/II PCT is an early-stage clinical trial designed to work out important design and feasibility details (scientific and operational) so that a later Phase III definitive trial can be well designed, efficient, and interpretable.

Is the goal to answer the final clinical effectiveness question with a smaller study?

No. The announcement is clear that these studies are not intended to answer the final, definitive clinical question using a smaller sample size and lower statistical power. The goal is to optimize the design of a future Phase III DCT, not to substitute for it.

What kinds of practical questions should the Phase I/II PCT address?

The emphasis is on core issues that determine whether a Phase III trial is feasible and well designed, including whether the intervention can be delivered as intended, whether participants can be recruited and retained, what outcome measures are most appropriate and sensitive to change, what dose or intensity should be used, and what study procedures are realistic in real-world clinical settings.

How does this opportunity relate to a future Phase III Definitive Clinical Trial (DCT)?

The Phase I/II PCTs funded under this opportunity are meant to produce the preliminary information needed to plan a later Phase III DCT. The intent is to improve the chances that the Phase III study is efficient, interpretable, and successful by resolving critical uncertainties early.

What funding mechanism is used for this opportunity?

The funding mechanism is an NIH R01 research project grant under a discretionary grant category.

What is the CFDA number associated with this program?

The CFDA number listed is 93.173, titled Research Related to Deafness and Communication Disorders.

Is cost sharing or matching required?

No. The listing states there is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds under the basic rules of the program.

Who is eligible to apply?

Eligibility is broad across U.S.-based organizations. Eligible applicants include public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), state and local governments (including county and city/township governments), special district governments, public housing authorities/Indian housing authorities, independent school districts, small businesses, and for-profit organizations other than small businesses.

Are there specific categories of institutions explicitly highlighted as eligible?

Yes. The announcement highlights additional eligible groups including Historically Black Colleges and Universities (HBCUs), Hispanic Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, tribally controlled colleges and universities (TCCUs), tribal organizations (including entities other than federally recognized tribal governments), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Are foreign institutions eligible to apply?

No. Foreign institutions are not eligible to apply under this opportunity.

Can a U.S. organization apply if the work will be conducted in a non-U.S. component of the organization?

No. The listing states that non-U.S. components of U.S. organizations are not eligible.

Are any international elements allowed at all?

Yes. While foreign institutions cannot apply and non-U.S. components of U.S. organizations are not eligible, the announcement notes that foreign components (as defined by NIH policy) are allowed when justified and compliant with NIH rules.

What is the funding opportunity number?

The funding opportunity number is PAR 11-290.

When was this opportunity posted?

The posting date listed is August 3, 2011.

Is this funding opportunity still active?

No. The administrative record indicates it is no longer active and is included for historical reference. The listing includes an archive date of April 24, 2012.

What dates in the record indicate the opportunity is no longer active?

The record shows multiple dates: a creation date of March 23, 2012; an original closing date of June 4, 2012; a listed current closing date of March 24, 2012; and an archive date of April 24, 2012. Taken together, these indicate the announcement has been archived and is not current.

Where was the full announcement hosted?

The full announcement was hosted through the NIH Grants Guide.

Who should be contacted for technical access issues related to the announcement?

The notice directed technical access issues to the NIH Office of Extramural Research (OER) webmaster contact provided in the announcement.

How does this opportunity align with NIDCD priorities?

The overall intent aligns with NIDCDs broader commitment to supporting rigorous, well-designed, and well-executed clinical trials focused on communication disorders, especially trials that build the groundwork needed for strong Phase III definitive studies.