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

Opportunity Summary:

The NIDCD Phase I/II Preliminary Clinical Trials in Communication Disorders (R01) opportunity (Funding Opportunity Number PAR-08-204) is a National Institutes of Health grant program designed to move promising interventions for communication disorders closer to definitive testing. Its central goal is to support early-stage clinical trials that generate the practical, decision-making evidence needed before launching a large, expensive Phase III Definitive Clinical Trial (DCT). In other words, this program is meant to fund the careful groundwork: studies that help investigators confirm feasibility, refine protocols, test recruitment and retention strategies, establish safety and tolerability where relevant, select or validate outcome measures, estimate effect sizes and variability for future power calculations, and work through real-world clinical and operational issues that can make or break a later Phase III trial.

A key point in the announcement is what these grants are not supposed to do. NIDCD is not looking for underpowered trials that attempt to answer the final, definitive clinical efficacy question on a smaller budget. Instead, these Phase I/II preliminary clinical trials are meant to optimize the design of an eventual Phase III DCT (referenced as PAR-08-205). The expected payoff is strong preliminary data that directly informs the go/no-go decision and improves the scientific rigor and efficiency of the later definitive trial. This typically includes evidence about whether the intervention can be delivered consistently, whether participants will enroll and adhere, whether the outcome metrics behave as expected in the target population, and what trial design choices (randomization approach, blinding strategies, dosing/intensity, follow-up duration, site logistics, etc.) are most likely to succeed at scale.

The mechanism of support is primarily the NIH R01 Research Project Grant. However, the announcement flags an important operational detail: applications that involve multiple sites or request $500,000 or more in direct costs in any single grant year may be converted to a U01 cooperative agreement at the time of award. That conversion signals that NIDCD staff would likely have substantial involvement in the project, which is typical for more complex, higher-cost, or multi-site clinical trial activities where closer coordination is beneficial.

Funding is not guaranteed and depends on federal appropriations as well as the volume and quality of applications received. The notice does not promise a fixed number of awards; instead it states that awards will be made only if funds are available and if enough meritorious proposals are submitted.

Eligibility is broad and includes many types of domestic organizations and governments. Eligible applicants include public and private institutions of higher education, nonprofits (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses and other for-profits), and multiple levels of government (state, county, city/township, special district, independent school districts, and public housing authorities). It also explicitly includes tribal entities and tribal-serving institutions, as well as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. The opportunity does not require cost sharing or matching.

As an archived funding announcement, the posted date was July 16, 2008, with a closing date of September 7, 2011, and an archive date of October 8, 2011. The CFDA number associated with this program is 93.173 (Research Related to Deafness and Communication Disorders). The full announcement was hosted through the NIH grants website under the referenced PAR number, and NIH Office of Extramural Research support contacts were provided for technical access and linking issues.

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