NIAMS Clinical Trial Planning Cooperative Agreement (U34) | Apply Online

Opportunity Summary:

The NIAMS Clinical Trial Planning Cooperative Agreement (U34) (Funding Opportunity Number PAR 15-166) is a National Institutes of Health discretionary funding opportunity designed specifically to fund the planning phase of investigator-initiated clinical interventional trials that fall within the mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Rather than paying for the full execution of a trial, this FOA focuses on supporting the detailed groundwork that has to be completed before a clinical trial can responsibly and efficiently begin. The goal is to help research teams move from a promising clinical-trial concept to a fully planned, well-documented, and operationally ready study.

This U34 mechanism is a cooperative agreement, meaning NIAMS is expected to have substantial involvement during the project period compared to a standard research grant. In practical terms, awardees should expect to work closely with NIAMS staff while refining the trial design and producing the core materials needed to launch the study. The planning grant supports the development of key elements such as the final protocol, recruitment and retention strategies, study timelines, data management and quality control plans, safety monitoring approaches, regulatory and ethics documentation, and other essential trial infrastructure. The FOA emphasizes milestone-driven progress, so applicants are expected to define clear planning milestones and then complete them during the U34 period.

A central point of this announcement is that the U34 is meant to be a precursor to a later clinical trial implementation application, typically through a U01 mechanism that would fund the actual conduct of the trial. NIAMS recommends completing the agreed-upon U34 milestones before moving forward with a U01 submission. In other words, the U34 is positioned as a structured bridge between early trial ideas and a full-scale implementation proposal, helping ensure that when the trial is proposed for execution, it is ready in terms of scientific rigor, feasibility, and operational detail.

The clinical trials targeted by this FOA must be hypothesis-driven, clearly focused on interventional research, and defined by measurable milestones. They must also align with NIAMS priorities in arthritis, musculoskeletal diseases, and skin diseases (CFDA 93.846) and be considered high priority by the Institute. This emphasis signals that NIAMS is looking for trials that are not only well designed, but also strategically important to the institute's research agenda and likely to produce meaningful clinical knowledge.

From an applicant eligibility standpoint, the FOA is broad and includes many U.S.-based organization types. Eligible applicants include state, county, city or township governments, special district governments, independent school districts, and public or state-controlled institutions of higher education, as well as private institutions of higher education. It also includes nonprofits (both those with and without 501(c)(3) status, with the non-501(c)(3) category explicitly allowed outside of higher education), small businesses, and for-profit organizations other than small businesses. The eligibility list also explicitly includes a variety of mission- or community-focused institution types such as Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Hispanic-Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), along with faith-based and community-based organizations and eligible federal agencies. Tribal governments and tribal organizations are included as eligible as well. However, non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible either, although foreign components (as NIH defines them in its policy statements) are allowed.

Financially, the opportunity lists an award ceiling of $250,000 and states there is no cost sharing or matching requirement. The FOA was posted March 31, 2015, with the original and current closing date listed as March 1, 2016, and an archive date of April 1, 2016. The administering agency is the National Institutes of Health, and additional details are provided through the NIH Grants Guide link associated with the announcement (http://grants.nih.gov/grants/guide/pa-files/PAR-15-166.html). For access or technical issues related to the announcement posting, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

Overall, this FOA is best understood as NIAMS support for rigorous trial readiness: it funds the disciplined planning work that can make the difference between a trial that struggles at startup and one that launches with a solid protocol, clear procedures, credible feasibility planning, and the documentation needed to move efficiently into an implementation-stage application.

Browse more opportunities from the same agency: National Institutes of Health

Browse more opportunities from the same category: Health

Next opportunity: Preventive Medicine Residency with Integrative Health Care Training Program

Previous opportunity: OJJDP FY 2015 VOCA Children s Advocacy Centers Subgrant Program

USGrants.org Applicant Portal:

Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.

Apply for PAR 15 166

 

[Watch] how do funding administrators access proposals?

Applicants also applied for:

Applicants who have applied for this opportunity (PAR 15 166) also looked into and applied for these:

 

Grant application guides and resources

It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!

Apply for Grants

 

 

Premium leads for funding administrators, grant writers, and loan issuers

Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.

If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.

Subscribe to Leads

 

Request more information:

Would you like to learn more about this funding opportunity, similar opportunities to "PAR 15 166", eligibility, application service, and/or application tips? Submit an inquiry below:

Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.