Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans Resource Access (X01 Clinical Trial Not Allowed) | PAR 18 768

Opportunity Information: Apply for PAR 18 768

Catalyzing Innovation in Late Phase Clinical Trial Design and Statistical Analysis Plans Resource Access (PAR 18-768) is an NIH opportunity sponsored by the National Heart, Lung, and Blood Institute (NHLBI) that is meant to strengthen the planning of investigator-initiated clinical trials in the heart, lung, blood, and sleep space. The central idea is not to fund the conduct of a clinical trial, but to give research teams access to specialized consultation that helps them design a late-phase study (Phase II and beyond) that is both feasible and methodologically strong. It is specifically aimed at trials where a traditional, straightforward randomized design may not be the best fit and where there is room for statistical novelty or innovation in the design and/or the statistical analysis plan.

The support offered through this announcement is framed as access to a consultative resource rather than a standard research grant that pays for enrollment, interventions, or follow-up. Awardees are connected to the Innovative Clinical Trials Resource (ICTR) (supported under an N01 mechanism), which provides expert input during the planning stage. In practical terms, this means applicants can seek help refining complex trial designs, working through challenging operational constraints for single-site or multi-site trials, and developing a rigorous statistical analysis plan that matches the scientific question and the realities of trial execution. The emphasis is on producing a well-designed and actionable trial plan that can answer an important clinical question aligned with NHLBI priorities.

A defining feature of this FOA is its focus on non-traditional designs and innovative statistical approaches. While the announcement text does not list specific design types, the intent typically covers situations where investigators may be considering adaptive features, pragmatic elements, enrichment strategies, cluster designs, novel endpoints, complex longitudinal outcomes, efficient randomization schemes, or other approaches that require careful statistical thinking and clear justification. The goal is to ensure that late-phase trials using these approaches are not only creative, but also credible, interpretable, and realistically implementable, with pre-specified methods that reduce ambiguity and improve the quality of eventual results.

This is an X01 resource access mechanism, and it is clearly labeled "Clinical Trial Not Allowed." That designation signals that the application itself should not propose to carry out a clinical trial under this award. Instead, the project period is focused on planning activities supported through consultation. The expected deliverable is essentially a stronger, more complete, and better-defended trial design package (including the statistical analysis plan) that could position a team for a later submission to conduct the trial under an appropriate clinical trial funding mechanism.

Eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, and city/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; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The FOA explicitly highlights additional eligible applicant groups 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, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions.

Foreign eligibility is limited in a way that matters for planning collaborations. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply directly. However, non-domestic components of U.S. organizations are eligible, and foreign components (as defined in the NIH Grants Policy Statement) are allowed. In other words, a U.S. applicant organization can include certain foreign elements or sites/components consistent with NIH policy, but a standalone foreign institution cannot be the applicant.

Administratively, this is a discretionary grant opportunity under NIH, categorized under health, and associated with CFDA numbers 93.233, 93.837, 93.838, 93.839, and 93.840. The original closing date listed in the source information is October 19, 2018, and the opportunity was created May 3, 2018. The award ceiling and expected number of awards are not specified in the provided source text, which is consistent with a resource-access style program where support is delivered primarily through structured consultation rather than large direct-cost research budgets.

Overall, the opportunity is best understood as a planning accelerator for sophisticated late-phase NHLBI-relevant trials: it helps investigators pressure-test trial concepts, resolve design and analysis complexities, and produce a high-quality, defensible statistical analysis plan and protocol framework before seeking funding to actually run the study.

• 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 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.)
• 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.

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