NIAID Clinical Trial Planning Grant (R34 Clinical Trials Not Allowed) | PAR 20 270

Opportunity Information: Apply for PAR 20 270

The NIAID Clinical Trial Planning Grant (R34 Clinical Trials Not Allowed), funding opportunity number PAR 20 270, is a discretionary NIH grant opportunity designed to help investigators do the upfront work required to launch a future, full-scale, investigator-initiated clinical trial. The focus of this award is not to run a clinical trial, but to complete the planning, design, and documentation that must be in place before a trial can responsibly and efficiently begin. In practical terms, the FOA is meant to support projects that will turn a strong clinical trial concept into an implementation-ready package, with a clear hypothesis, a well-defined set of milestones, and a design aligned with the National Institute of Allergy and Infectious Diseases (NIAID) mission and NIAID-identified high-priority research areas (as referenced on NIAID's mission and research priorities website).

This R34 mechanism is specifically positioned as a planning grant for hypothesis-driven clinical trials. Applicants are expected to use the project period to refine the scientific and operational elements needed for a later trial application, such as finalizing the protocol and statistical analysis plan, confirming feasibility, establishing recruitment and retention strategies, detailing data management and quality control procedures, and preparing the essential regulatory and oversight documentation. The emphasis on milestone-defined work signals that NIAID expects applicants to propose measurable deliverables and decision points that demonstrate progress toward a trial that is ready for execution. While the planned future study is a clinical trial, the FOA title makes clear that clinical trials are not allowed under this particular award, meaning the R34 funds are intended for planning activities rather than enrolling participants and conducting the trial itself.

The opportunity is categorized under Health and is associated with CFDA number 93.855. It is offered by the National Institutes of Health, with NIAID as the relevant institute driving the scientific priorities. The award ceiling is listed as $150,000, indicating the maximum award amount anticipated per project under this announcement. The original closing date provided is 2023-05-12, and the FOA creation date is 2020-08-05.

Eligibility is broad and includes many types of domestic U.S. organizations and governmental entities, such as state, county, city or township governments; special district governments; independent school districts; and public housing authorities/Indian housing authorities. Eligible higher education applicants include public and state-controlled institutions of higher education as well as private institutions of higher education. The FOA also allows participation from federally recognized Native American tribal governments and other Native American tribal organizations that are not federally recognized tribal governments. Nonprofit organizations are eligible whether or not they have 501(c)(3) IRS status (so long as they are not institutions of higher education in those nonprofit categories), and for-profit organizations are eligible as well, including small businesses and other for-profit entities that are not small businesses. The announcement also explicitly highlights additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible agencies of the federal government; regional organizations; U.S. territories or possessions; and non-domestic (non-U.S.) entities (foreign organizations).

Overall, this FOA is best understood as a bridge between an early-stage clinical trial idea and a later, fully powered clinical trial application. It is aimed at investigators who have a compelling, NIAID-relevant clinical trial question and need support to complete the rigorous planning work that reduces risk, improves feasibility, strengthens protocol quality, and increases the likelihood that a subsequent clinical trial will be well-designed, operationally realistic, and ready to implement.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAID Clinical Trial Planning Grant (R34 Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2020-08-05.
• Applicants must submit their applications by 2023-05-12. (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 $150,000.00 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.

Apply for PAR 20 270

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