NIAMS Clinical Trial Planning Grant (R34) - Clinical Trial Not Allowed | PAR 20 090

Opportunity Information: Apply for PAR 20 090

The NIAMS Clinical Trial Planning Grant (R34) opportunity (PAR 20-090) is a National Institutes of Health discretionary grant designed to fund the early, pre-launch work needed to responsibly start an investigator-initiated clinical interventional trial within the mission areas of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The focus is not on running the clinical trial itself, but on doing the detailed planning, design, and documentation work that must be in place before a full clinical trial implementation application is submitted. In practical terms, this award supports the groundwork that turns a strong clinical trial idea into a well-specified, operationally feasible, and compliant study package.

The R34 mechanism is intended for hypothesis-driven trials that have clearly defined milestones and the potential for high impact in NIAMS-relevant research. The planning phase typically includes refining the scientific aims and intervention approach, finalizing study design elements (such as eligibility criteria, endpoints, visit schedules, and statistical considerations), building out recruitment and retention strategies, and preparing the regulatory and operational materials needed for launch. This can also include creating or finalizing key trial documents such as the protocol, informed consent templates, manual of procedures, data and safety monitoring plans appropriate to the study risk, case report forms, and data management and quality control processes. The overall goal is to reduce avoidable delays and failures later by ensuring the trial is implementable and well justified before seeking larger-scale support.

A major point in the announcement is the intended pathway: successful completion of the agreed-upon R34 milestones is recommended before applying for a U01 clinical trial implementation award that would fund the actual conduct of the clinical trial. In other words, the R34 is positioned as a structured bridge between concept and execution. Applicants should expect to define concrete planning milestones and deliverables that can be assessed, since the mechanism emphasizes milestone-defined progress rather than open-ended exploratory work.

Although the title includes the phrase "Clinical Trial Not Allowed," the description clarifies that the funded activity is clinical trial planning for interventional studies, not enrollment and intervention delivery under this award. The intent is that the R34 funds the preparatory phase only, with trial implementation occurring under a separate mechanism (commonly a U01) if the planning work demonstrates readiness and the subsequent application is successful.

Eligibility is broad and includes many U.S.-based organization types commonly eligible for NIH grants. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, certain tribal governments that are not federally recognized, and U.S. territories or possessions.

Restrictions on foreign involvement are also spelled out. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant organization may include certain foreign activities or collaborations when they meet NIH policy definitions and are justified for the project.

From the funding details provided, the award ceiling is listed as $250,000. The catalog reference is CFDA 93.846, and the agency is the National Institutes of Health. The FOA record indicates an original closing date of 2022-08-10 and a creation date of 2020-01-14. Overall, the opportunity is best viewed as targeted support for producing a complete, high-quality clinical trial plan and the core documents needed to move efficiently into a subsequent implementation award, with a strong emphasis on defined milestones, feasibility, and alignment with NIAMS priorities.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAMS Clinical Trial Planning Grant (R34) - Clinical Trial Not Allowed" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846.
• This funding opportunity was created on 2020-01-14.
• Applicants must submit their applications by 2022-08-10. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $250,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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