NIDCD Phase III Definitive Clinical Trials in Communication Disorders (R01) | Apply Online

Opportunity Summary:

The NIDCD Phase III Definitive Clinical Trials in Communication Disorders (R01) funding opportunity (PAR-08-205) is a National Institutes of Health grant program designed to support rigorous, investigator-initiated Phase III definitive clinical trials aimed at establishing treatments or interventions that are both safe and effective for communication disorders. The emphasis is on late-stage trials that are ready to provide clear, practice-changing answers. Projects proposed under this announcement are expected to be capable of producing results that could meaningfully influence clinical practice guidelines and/or inform public health policy if the intervention proves successful.

A key expectation of this opportunity is that applicants are not starting from scratch. By the time a team applies for this Phase III definitive trial support, the underlying foundation should already be in place, including adequate preclinical evidence and preliminary clinical findings that justify moving into a definitive Phase III trial. In addition, the major design and operational questions that can derail large trials should already be resolved before submission. That includes having core clinical and methodological decisions worked out in advance, such as the target population definition, primary and secondary outcomes, recruitment and retention strategies, randomization and masking where appropriate, intervention delivery procedures, data collection workflows, safety oversight plans, and data management/quality control approaches.

One of the most important concrete requirements in the announcement is the expectation of a complete Manual of Procedures (MOP). The MOP is not optional: it must be included as an appendix to the Phase III Definitive Clinical Trial application. This requirement signals that NIDCD is looking for proposals that are operationally ready to run, with standardized procedures clearly documented so that trial conduct is consistent across staff, sites, and participants. The FOA also notes that applicants can use earlier-stage NIDCD mechanisms to prepare for this step, specifically the NIDCD Clinical Trial Planning Grant (R34) (PAR-08-203) and/or the NIDCD Phase I/II Preliminary Clinical Trial FOA (PAR-08-204), which are intended to help gather the remaining planning information and develop the MOP needed for a Phase III launch.

In terms of award structure, the program uses the NIH Research Project Grant (R01) mechanism as the default. However, the announcement includes an important caveat: if a project is a multicenter Phase III definitive clinical trial or if it requests $500,000 or more in direct costs in any grant year, the award will be converted to a cooperative agreement mechanism (U01). That conversion generally indicates a higher level of NIH programmatic involvement and coordination expectations typical for large, complex, and/or multicenter clinical trials.

Funding under this FOA is contingent on appropriations and on the availability of a sufficient number of highly rated, meritorious applications, and the announcement does not guarantee a specific number of awards. The program is categorized as discretionary funding and falls under the health funding activity category, with CFDA number 93.173 (Research Related to Deafness and Communication Disorders). There is no cost sharing or matching requirement.

Eligibility is broad and includes many types of organizations that commonly apply for NIH funding. Eligible applicants listed include state, county, city/township, and special district governments; public and private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; nonprofits both with and without 501(c)(3) status; and for-profit organizations other than small businesses, as well as small businesses. Tribal entities are included, both federally recognized tribal governments and other tribal organizations, and the eligibility information also explicitly references Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), regional organizations, faith-based or community-based organizations, eligible federal agencies, and U.S. territories or possessions.

Administratively, the opportunity was posted July 16, 2008, later recorded with a creation date of March 23, 2012, and it is archived (original closing date September 7, 2012; current closing date shown as March 24, 2012; archive date April 24, 2012). The full announcement is referenced through the NIH grants guide, and the NIH Office of Extramural Research provides a webmaster contact for access or linking issues.

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Next opportunity: Investigations on Primary Immunodeficiency Diseases (R01)

Previous opportunity: NIDCD Phase I/II Preliminary Clinical Trials in Communication Disorders (R01)

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