Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (U34 Clinical Trial Not Allowed) | RFA HL 19 027

Opportunity Information: Apply for RFA HL 19 027

Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (RFA-HL-19-027) is a National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI) funding opportunity that uses the U34 cooperative agreement mechanism to support planning work for investigator-initiated late-phase clinical trials. The emphasis is on phase II and later studies that address important clinical questions aligned with NHLBI’s mission areas (heart, lung, blood, and sleep-related conditions) and that would benefit from non-traditional or otherwise innovative trial designs, particularly where there is room for statistical novelty. A central idea of the program is that some high-impact clinical questions are difficult to answer efficiently with conventional parallel-group randomized designs, so the FOA encourages planning that incorporates newer design and analytic approaches when they are scientifically justified and operationally feasible.

The award is explicitly for planning activities rather than running the clinical trial itself, and it is labeled “Clinical Trial Not Allowed,” meaning the funded work should not include conducting an interventional clinical trial under this award. Instead, applicants are expected to use the support period to build a strong, feasible, and well-justified trial plan that can later compete for implementation funding through an appropriate mechanism. Planning activities typically include refining the scientific rationale and aims; selecting and justifying the innovative design features; developing a detailed and defensible Statistical Analysis Plan (SAP); confirming feasibility through recruitment projections and site readiness assessments; defining endpoints and outcome ascertainment methods; addressing data quality, missing data, multiplicity, and interim monitoring concepts; and laying out operational workflows such as randomization procedures, data collection schedules, and protocol-driven safety oversight. The NHLBI also highlights the role of consultative support from the Innovative Clinical Trials Resource (ICTR) (N01), indicating that awardees are expected to incorporate expert consultation to strengthen design choices, analytic methods, and overall trial readiness.

Because this is a cooperative agreement, the relationship with NHLBI is typically more interactive than a standard research grant, with NIH staff likely to have substantial involvement in shaping milestones, ensuring the planning products are on track, and helping align the proposed approach with NHLBI expectations for rigor, feasibility, and eventual implementability. The end products are meant to be practical and decision-ready, such as a near-final protocol, a complete SAP, and supporting materials that would allow a subsequent trial application to be submitted with fewer unresolved design or operational risks.

Eligibility is broad and includes many U.S.-based organization types: state, county, and local governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; nonprofits with and without 501(c)(3) status (excluding institutions of higher education when specified in the listing); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA also calls out additional categories 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), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply as applicant organizations, but non-U.S. components of U.S. organizations may be included, and foreign components are allowed as defined by NIH policy, which supports appropriate international collaboration when it strengthens the science.

From a funding details standpoint, the opportunity falls under NIH’s health activity category and references multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840). The listed award ceiling is $125,000, reflecting the planning-focused scope rather than full trial execution costs. The original closing date provided is October 19, 2018, and the FOA was created on May 3, 2018, which is helpful context if someone is reviewing it historically or looking for successor announcements. Overall, the program is designed to lower the barriers to launching well-designed late-phase trials by funding the intensive front-end work needed to responsibly use innovative designs and advanced statistical planning, with the goal of producing trial plans that are both methodologically strong and realistically implementable.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (U34 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): 93.233, 93.837, 93.838, 93.839, 93.840.
• This funding opportunity was created on 2018-05-03.
• Applicants must submit their applications by 2018-10-19. (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 $125,000.00 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 RFA HL 19 027

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