NIDCR Clinical Trial Planning Grant (R34) | Apply Online

Opportunity Summary:

The NIDCR Clinical Trial Planning Grant (R34) opportunity (Funding Opportunity Number PAR 08-195) is a discretionary NIH grant program run through the National Institute of Dental and Craniofacial Research (NIDCR). Its central aim is to fund the detailed planning work needed before launching an investigator-initiated interventional clinical trial in the dental, oral, and craniofacial space. Rather than paying for the full execution of a trial, this mechanism supports the upfront effort required to design the study rigorously and prepare all the core materials that would be expected in a later full-scale trial application.

This FOA is specifically focused on planning for Phase I, II, III, or IV interventional clinical trials, and it explicitly includes interventional behavioral studies (often described as Stage I through Stage IV behavioral intervention research). The intent is to help investigators move from an early-stage idea to a trial-ready package by funding comprehensive planning, design, and documentation. A major theme is quality control before large amounts of money and participant effort are committed: the R34 allows early peer review of the trial rationale and early assessment of the proposed design and implementation approach, so weaknesses can be identified and corrected before a full clinical trial proposal is submitted.

A key expected outcome of an R34 award under this announcement is a complete, trial-ready clinical trial protocol plus the supporting documents needed to run the study consistently across staff and sites. The FOA highlights development of a Manual of Procedures as a central deliverable, alongside other associated trial documents. These materials are not optional extras; they are required components for any subsequent application to implement the clinical trial through NIDCR’s cooperative agreement mechanism (U01). In other words, the R34 is intended to produce the blueprint, operating playbook, and documentation package that makes a later implementation application feasible and credible.

The FOA also makes clear what NIDCR expects at the end of the planning period. The product of the R34 should be either (1) a submitted application for a clinical trial implementation cooperative agreement (U01), or (2) a written report that summarizes what planning work was completed and explains why the project is not moving forward to a U01 application. This second option acknowledges a practical reality: careful planning sometimes reveals that a proposed trial is not yet justified, not feasible, or not optimally designed, and NIDCR is signaling that reaching a well-supported “no-go” decision can be an acceptable outcome if it is based on solid planning work.

One of the most important administrative requirements in this opportunity is that applicants must obtain pre-approval from NIDCR before submitting an R34 application. That means investigators should expect to communicate with NIDCR program staff ahead of submission to confirm that the proposed planning effort fits NIDCR’s priorities and the intent of the mechanism. This requirement is emphasized as a condition of submission, not merely a suggestion.

In terms of funding structure, this program uses the NIH R34 mechanism, designated here as the NIDCR Clinical Trial Planning grant mechanism. Awards are contingent on the availability of funds and on the submission of meritorious applications, and the announcement does not guarantee a specific number of awards. The activity category is Health, and the CFDA listing associated with the program is 93.121 (Oral Diseases and Disorders Research). There is no cost sharing or matching requirement stated for applicants.

Eligibility is broad and includes many common applicant types across NIH: public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), for-profit organizations (including small businesses), and various government entities (state, county, city/township, special districts, independent school districts, public housing authorities, and certain tribal governments and organizations). The eligibility list also extends to several institution types often highlighted in federal funding, such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and faith-based or community-based organizations. Notably, the announcement also indicates that non-U.S. entities (foreign organizations), regional organizations, eligible federal agencies, and U.S. territories or possessions may be eligible, as described in the eligibility clarification text.

Historically, this opportunity was posted July 9, 2008, with an original and current closing date listed as September 7, 2011, and it was archived October 8, 2011. The full announcement was hosted through the NIH Grants Guide under the “PAR 08-195” identifier. Contact assistance for accessing the electronic announcement was routed through the NIH Office of Extramural Research (OER) webmaster email listed in the notice.

Overall, the practical value of this FOA is that it funds the often under-resourced but make-or-break phase of clinical trial development: refining the scientific rationale, locking down the study design, building operational plans, and producing the protocol and procedural documentation needed to credibly request implementation funding later. It is best understood as a bridge between an intervention concept and a fully implementable NIDCR-supported clinical trial submitted as a U01, with an emphasis on early rigor, feasibility, and well-documented execution plans.

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