Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (X01) | RFA HL 18 009

Opportunity Information: Apply for RFA HL 18 009

Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans (X01) is a National Institutes of Health (NIH) funding opportunity from the National Heart, Lung, and Blood Institute (NHLBI) designed to help investigators strengthen the planning of late-phase clinical trials. The focus is on phase II and beyond, and the trials can be run at a single site or across multiple sites. What makes this opportunity distinct is that it is aimed at investigator-initiated studies that tackle important heart, lung, blood, and sleep related clinical questions and that would benefit from non-traditional trial designs, especially designs that create room for statistical innovation or novel analytic approaches. Rather than primarily paying for running the trial itself, the core value of this X01 mechanism is providing structured access to expert consultation to help investigators build a trial plan that is both feasible and scientifically strong.

The program supports planning activities by connecting applicants with consultative services through the Innovative Clinical Trials Resource (ICTR) under an NHLBI contract mechanism (N01). In practical terms, the award is meant to catalyze better trial design and better statistical analysis planning before the trial launches. That includes refining the design to match the clinical question, anticipating operational and analytic challenges, and producing a credible statistical analysis plan suited to complex or innovative designs. This is particularly relevant for studies considering approaches outside the standard two-arm randomized controlled trial format, where issues like adaptations, clustering, pragmatic elements, unusual endpoints, complex randomization, or other design features can introduce added statistical and logistical complexity.

The opportunity is listed as RFA HL 18 009 and uses the X01 activity code, which signals a resource access award rather than a traditional research project grant. It sits within the NIH health funding activity category and is associated with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840. The stated goal is to produce feasible, well-designed late-phase trials by providing specialized input at the planning stage, with an emphasis on designs where there is genuine opportunity for statistical novelty and/or innovation while staying aligned with NHLBI mission priorities.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. 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 (both with and without 501(c)(3) status); for-profit organizations other than small businesses; and small businesses. The announcement also explicitly highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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 restricted in a specific way. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization. However, non-domestic components of U.S. organizations are eligible to apply, and foreign components (as defined in NIH policy) are allowed, meaning a U.S. applicant can include certain foreign collaboration or performance sites when justified and consistent with NIH Grants Policy Statement rules. This setup preserves the award as U.S.-anchored while still permitting international elements when they add scientific or operational value.

The original closing date listed for this opportunity was 2017-05-19, with a creation date of 2017-05-17, indicating it was published very close to its deadline. The award ceiling and expected number of awards are not specified in the provided source data, which is consistent with resource-access style opportunities where the primary benefit may be consultation time and specialized support rather than a standard budget structure. Overall, the program is best understood as a way for investigators planning complex, late-phase NHLBI-relevant trials to get high-level design and statistical guidance early enough to materially improve rigor, feasibility, and readiness for subsequent trial execution funding or implementation.

• 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 (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 2017-05-17.
• Applicants must submit their applications by 2017-05-19. (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 RFA HL 18 009

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: