NIDCD Definitive Phase III Clinical Trial Planning Grant (R34) | Apply Online

Frequently Asked Questions (FAQs): NIDCD Definitive Phase III Clinical Trial Planning Grant (R34) (PAR-09-142)

What is PAR-09-142?

PAR-09-142 is the NIDCD Definitive Phase III Clinical Trial Planning Grant (R34), a National Institutes of Health (NIH) discretionary funding opportunity intended to support the planning work required to prepare a large-scale, multicenter Phase III definitive clinical trial in topic areas relevant to the National Institute on Deafness and Other Communication Disorders (NIDCD).

What is the main purpose of this R34 planning grant?

The main purpose is to fund intensive, up-front planning activities so a Phase III definitive clinical trial concept can be developed into a complete, implementation-ready protocol package. A central goal is to enable early peer review of the proposed trial concept, including the scientific rationale, overall design, organizational structure, and practical implementation plan, before seeking support to conduct the full Phase III trial.

Does this grant pay for conducting the Phase III clinical trial?

No. This R34 mechanism is designed to support planning and preparation for a Phase III definitive clinical trial. It is not intended to pay for the full conduct of the Phase III trial itself.

What major product or deliverable is expected from the R34 planning period?

A major deliverable is a detailed Manual of Procedures (MOP). The MOP is described as a required component for a subsequent application to conduct the Phase III definitive clinical trial under the related NIDCD Phase III funding opportunity referenced as PAR-08-205.

What is a Manual of Procedures (MOP) in the context of this opportunity?

In this opportunity, the MOP is where the planned Phase III trial becomes operational across sites. It is intended to document standardized procedures and implementation details so multiple centers can execute the study consistently.

What kinds of details are included in the Manual of Procedures (MOP) according to the announcement summary?

Based on the description provided, the MOP is expected to include standardized procedures across sites, how the intervention and comparison conditions will be delivered, eligibility criteria and enrollment workflows, outcomes and measurement schedules, and quality assurance steps designed to reduce site-to-site variability.

Why does this FOA emphasize planning and early peer review?

The FOA emphasizes planning to reduce preventable errors, protocol ambiguities, and site-to-site variability when a multicenter Phase III trial launches. It also seeks to support early peer review of the trial concept and implementation approach before an applicant requests funding to conduct the full Phase III effort.

What types of activities can the R34 planning grant support?

The planning grant supports activities associated with preparing a multicenter Phase III definitive trial, including developing the MOP, organizing the research team and trial governance structure, establishing tools and processes for data management, setting up oversight procedures appropriate for a large clinical trial, and developing recruitment and retention strategies.

Is this funding opportunity intended for early-stage or exploratory clinical studies?

No. The FOA explicitly states it is not intended to support smaller early-stage clinical studies and excludes Phase I/II preliminary clinical trials.

If my project is a Phase I or Phase II preliminary clinical trial, where should I apply?

The FOA directs applicants interested in Phase I/II preliminary clinical trials to the separate NIDCD Phase I/II Preliminary Clinical Trials in Communication Disorders announcement referenced as PAR-08-204.

What NIH grant mechanism is used for PAR-09-142?

PAR-09-142 uses the NIH R34 mechanism, which is commonly used for clinical trial planning activities.

How long are awards under this opportunity, and what is the expected award size?

The opportunity indicates that size and duration are expected to vary because planning needs can differ substantially depending on the intervention, the number of sites, and the complexity of the trial.

Is cost sharing or matching required?

No. The opportunity states there is no cost sharing or matching requirement.

Who is eligible to apply?

Eligibility is described as broad and includes many U.S.-based organizations and government entities. Examples listed include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (including small businesses and other for-profits); public housing authorities/Indian housing authorities; and Native American tribal governments and organizations (federally recognized and other than federally recognized, as specified).

Are minority-serving institutions and community-based organizations included in the eligible applicant types?

Yes. The eligibility information highlights additional categories such as Alaska Native and Native Hawaiian Serving Institutions, Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, and regional organizations.

Are U.S. territories or federal agencies mentioned as eligible?

Yes. The eligibility information includes eligible federal agencies and U.S. territories or possessions.

What research area does this opportunity fall under administratively (CFDA number)?

The opportunity is associated with CFDA number 93.173, titled Research Related to Deafness and Communication Disorders.

What is the relationship between PAR-09-142 and PAR-08-205?

PAR-09-142 is a planning grant intended to produce planning deliverables (including the MOP) in preparation for a later application to conduct a Phase III definitive clinical trial under the related NIDCD Phase III funding opportunity referenced as PAR-08-205.

Where can I find the full announcement?

The full announcement is referenced as being available on the NIH Grants Guide site at http://grants.nih.gov/grants/guide/pa-files/PAR-09-142.html.

Is this funding opportunity currently open?

The record information provided indicates closing and archival dates from 2012 and describes the posted version as historical/archived rather than an active, open competition.

What are the key dates mentioned in the record summary?

The notice is described as originally posted on April 3, 2009, and the record also shows later administrative dates (including a creation date of March 23, 2012) as well as closing and archival dates from 2012.

Who should be contacted for access or linking issues related to the posting?

The NIH Office of Extramural Research (OER) webmaster contact is provided for access or linking issues: FBOWebmaster@OD.NIH.GOV.

What is meant by “multicenter” in the context of this planning grant?

In the context of this opportunity, “multicenter” refers to a Phase III definitive clinical trial expected to be conducted across multiple locations/sites, which increases the need for standardized procedures, coordinated governance, consistent data handling, and quality assurance to limit site-to-site variability.

Why are recruitment and retention strategies specifically mentioned?

The summary notes that recruitment and retention are often pivotal for Phase III success due to larger sample sizes and the need to enroll participants across multiple locations, so the planning grant supports development of strategies for both recruitment and retention.

What kinds of organizational and oversight elements are supported during planning?

The planning grant supports assembling and organizing the research team and trial governance structure, establishing data management tools and processes, and setting up oversight procedures appropriate for a large clinical trial.