Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (U34) | RFA HL 18 008

Opportunity Information: Apply for RFA HL 18 008

Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (U34) is a National Institutes of Health funding opportunity from the National Heart, Lung, and Blood Institute (NHLBI) designed to support the planning stage of investigator-initiated clinical trials in phase II and later. The central goal is to help research teams turn important NHLBI-relevant clinical questions into feasible, well-justified, and operationally sound trial proposals, especially when the trials require non-traditional designs that create room for statistical novelty or methodological innovation. Rather than paying primarily for running a full clinical trial, this mechanism focuses on the preparatory work needed to produce a high-quality late-phase trial design and a rigorous statistical analysis plan that can stand up to scientific, regulatory, and real-world implementation demands.

A distinguishing feature of this opportunity is its emphasis on innovative trial design approaches. Applicants are expected to be working on late-stage clinical trials that do not fit neatly into conventional randomized controlled trial templates and that benefit from advanced design or analysis strategies. In practice, this can include designs such as adaptive trials, pragmatic trials embedded in health systems, cluster-randomized approaches, platform or master protocol concepts, enrichment strategies, Bayesian or other novel inferential frameworks, or other non-traditional methods aimed at improving efficiency, ethical conduct, interpretability, or generalizability. The FOA is positioned for projects where statistical thinking is not an afterthought, but a central driver of trial credibility and impact.

The award is a cooperative agreement (U34), which signals that NHLBI expects an active partnership role rather than a purely hands-off grant. A key part of that partnership is the use of consultative services from the Innovative Clinical Trials Resource (ICTR) under an N01 contract. The intent is to pair awardees with specialized expertise to refine and strengthen the trial plan, including design decisions, operational feasibility, endpoint selection, data collection strategy, randomization and masking procedures where applicable, and the statistical analysis plan. This consultative structure is meant to reduce avoidable design flaws and improve the likelihood that the eventual full-scale trial proposal will be both innovative and realistic to execute across single-site or multi-site settings.

The planning activities supported under this FOA generally align with what is needed to move from a promising clinical question to a trial that is ready for launch or ready for a subsequent, larger funding application. That includes developing a complete protocol framework, specifying primary and secondary endpoints, finalizing sample size and power or precision justifications suited to the chosen design, laying out interim monitoring rules if relevant (for example in adaptive settings), and producing a detailed statistical analysis plan that anticipates real-world complications such as missing data, non-adherence, site heterogeneity, multiplicity, subgroup analyses, and sensitivity analyses. Because the FOA highlights feasibility and good design, it implicitly favors planning packages that show a clear path to implementation, including recruitment and retention strategies, site readiness considerations, and practical data management approaches.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants listed include state, county, and city or township governments; 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; public housing authorities and Indian housing authorities; and a range of nonprofit organizations (both with and without 501(c)(3) status) outside of higher education. For-profit organizations (other than small businesses) and small businesses are also eligible, as are certain other categories. The FOA explicitly calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and 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; Indian/Native American tribal governments other than federally recognized; and U.S. territories or possessions.

The foreign eligibility rules are nuanced. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the primary applicant organization. However, non-domestic components of U.S. organizations are eligible, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are allowed. In practical terms, that means a U.S. applicant can include foreign sites or collaborations when they are well justified and appropriately structured, but an organization based outside the U.S. cannot be the applicant institution for this U34.

From an administrative standpoint, this opportunity is categorized as discretionary funding and uses the health funding activity category. The opportunity number is RFA HL 18 008, and the funding opportunity title is as listed above. CFDA numbers associated with it include 93.233 and 93.837 through 93.840. The original closing date provided is January 12, 2018, and the creation date is May 17, 2017. The award ceiling listed is $125,000, which reinforces the planning-focused nature of the mechanism rather than full trial execution. The expected number of awards is not specified in the provided data.

Overall, the FOA is best understood as a targeted planning grant for teams preparing late-phase NHLBI-aligned clinical trials where the design and analysis require creativity and sophistication. It aims to reduce the gap between a compelling clinical question and a fundable, executable protocol by supporting intensive design and analysis planning, strengthened through consultation with NHLBI-supported clinical trials methodology resources.

• 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)" 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 2017-05-17.
• Applicants must submit their applications by 2018-01-12. (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 $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 18 008

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