Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans Resource Access (X01) | PAR 17 294

Opportunity Information: Apply for PAR 17 294

Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans Resource Access (X01) (PAR-17-294) is a National Institutes of Health funding opportunity sponsored by the National Heart, Lung, and Blood Institute (NHLBI). Its core goal is not to directly fund a full clinical trial, but to give investigators access to expert, hands-on consulting support to plan late-phase clinical trials (Phase II and beyond). The opportunity is aimed at investigator-initiated trials, whether single-site or multi-site, that tackle important clinical questions aligned with NHLBI's mission areas (heart, lung, blood, and sleep-related conditions and disorders) and that would benefit from non-traditional trial designs where there is room for real statistical novelty or methodological innovation.

The emphasis on "late phase" and "critical clinical questions" signals that applicants should already have a strong clinical premise and a plausible path toward a definitive evaluation of an intervention, strategy, or clinical approach. What makes this FOA distinct is the explicit encouragement of designs that go beyond standard randomized parallel-group trials. In practice, that could mean adaptive designs, platform or master protocol approaches, pragmatic trials, cluster randomization, stepped-wedge designs, Bayesian methods, enrichment strategies, or other modern approaches where the design and statistical analysis plan need specialized expertise to be both rigorous and feasible. The FOA is meant to strengthen the scientific and operational foundations of such trials so they are more likely to succeed in later funding stages and in real-world execution.

Rather than building a new consulting structure at each institution, this FOA routes awardees to an established consultative service: the Innovative Clinical Trials Resource (ICTR), supported under an NHLBI contract mechanism (N01). Through the X01 resource access mechanism, investigators can receive targeted planning assistance that typically includes refining the trial design, clarifying endpoints, improving randomization and monitoring strategies, addressing statistical power and sample size issues, developing a defensible statistical analysis plan, and working through feasibility constraints such as recruitment assumptions, site variability, protocol complexity, and operational timelines. The overall intended outcome is a well-justified, well-specified, and practically executable late-phase trial plan that can stand up to peer review and to real-world conduct.

Eligibility is broad and includes many domestic applicant types across government, academia, nonprofit, and industry. 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; tribal organizations that are not federally recognized; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education when applicable); for-profit organizations other than small businesses; small businesses; and other organizations that NIH deems eligible. The announcement also explicitly highlights a range of institution types and community-facing organizations as eligible, including Alaska Native and Native Hawaiian 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 federal agencies, regional organizations, and U.S. territories or possessions.

Foreign eligibility is more limited. Non-domestic (non-U.S.) entities and non-U.S. foreign institutions are not eligible to apply as the primary applicant organization. However, non-domestic components of U.S. organizations may participate, and foreign components are allowed as defined by the NIH Grants Policy Statement. In other words, the applicant organization must be domestic, but it may include certain international elements or sites if they are structured as allowable foreign components within the NIH policy framework.

Administrative details in the source information show this is a discretionary grant opportunity with a grant funding instrument, categorized under health-related activities, and associated with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840. The original posting was created on 2017-05-19, and the original closing date listed is 2018-01-12. The key practical takeaway is that this FOA is designed as a catalyst: it helps investigators strengthen and innovate the design and statistical underpinnings of late-phase NHLBI-relevant clinical trials by connecting them to a dedicated expert resource, with the intent of producing a feasible, high-quality trial plan suitable for execution and future support.

• 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 Resource Access (X01)" 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 2017-05-19.
• 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.)
• 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 17 294

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