The Blood and Marrow Transplant Clinical Trials Network - Data Coordinating Center (U24 Clinical Trial Not Allowed) | RFA HL 24 011

Opportunity Information: Apply for RFA HL 24 011

The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Data Coordinating Center funding opportunity (RFA-HL-24-011) is an NIH cooperative agreement (U24) intended to strengthen and sustain the infrastructure needed to run complex, multi-site clinical research in hematopoietic cell transplantation (HCT) and related cell therapy (CT). The central goal is to move the field forward for all transplant-eligible patients, with a clear emphasis on populations that are especially hard to study and treat, such as patients with rare non-malignant blood disorders and patients with hematologic cancers where current approaches are limited or outcomes remain poor. In practical terms, NIH is supporting a coordinated network that can design and execute rigorous trials testing new transplant strategies, novel cellular therapies, and improvements in supportive care and long-term outcomes.

A key feature of the opportunity is the creation or continuation of a Data Coordinating Center (DCC) that serves as the operational and scientific backbone for the network. The DCC is expected to manage the core functions that make multi-center trials feasible and credible: protocol coordination, data management and quality control, regulatory and operational harmonization across sites, statistical design and analysis, trial monitoring, and efficient reporting to stakeholders. Alongside the DCC, NIH will support core clinical sites and a limited number of trials directly through funds requested under this initiative, while also anticipating that additional studies and trials will be brought into the network through partnerships. Those partnerships may include collaborations with R01-funded investigators, industry sponsors, and disease foundations, which helps expand the network research portfolio beyond what can be covered by the U24 award alone.

The announcement highlights why a longer performance period is necessary for transplantation and cell therapy research. HCT and CT trials often extend beyond the typical five-year window due to several built-in realities: eligible patient populations can be small (especially for rare diseases), which can stretch enrollment over multiple years; cell manufacturing and product logistics can be complex and time-consuming; and many of the outcomes that matter most in transplant medicine occur well after the procedure. The notice specifically points to composite and longer-horizon endpoints like disease-free survival and chronic graft-versus-host disease (GVHD)-free survival, which may not be fully observed until two or more years after transplant. Because of these constraints, NIH indicates that a seven-year program is needed to properly enroll participants, follow them long enough to capture meaningful endpoints, and complete analyses that can change clinical practice.

This opportunity is categorized under Education and Health and is associated with CFDA numbers 93.395 and 93.839. It is offered by the National Institutes of Health, with an original closing date of October 2, 2023, and a creation date of June 20, 2023. While the source text does not specify an award ceiling or the expected number of awards, the structure described makes clear that NIH is investing in sustained national coordination capacity rather than a short, single-project effort.

Eligibility is broad across U.S.-based organizations and government entities, reflecting the national scope of the network and the diverse institutions involved in transplant research and delivery. Eligible applicants include state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories as stated); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement also explicitly calls out additional eligible institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

At the same time, the opportunity is restrictive with respect to foreign involvement. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by the NIH Grants Policy Statement are not allowed. In other words, the applicant organization and the supported components must be domestic, which simplifies governance, compliance, and oversight for a U.S.-funded clinical trials network.

Finally, the title includes an important administrative boundary: "Clinical Trial Not Allowed." In NIH terms, that generally means the U24 mechanism itself is not intended to be used by the awardee to propose and independently conduct a clinical trial as the primary funded activity under the grant. Instead, the focus is on infrastructure and coordination for the network, with trial activities supported in a controlled and networked way as described in the announcement (including a limited number of trials and additional trials supported through collaborations). The overall intent is to ensure the field has the long-term coordinating capacity to run high-quality HCT and CT studies that are difficult to execute without centralized data, statistical, operational, and regulatory leadership.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "The Blood and Marrow Transplant Clinical Trials Network - Data Coordinating Center (U24 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): 93.395, 93.839.
• This funding opportunity was created on 2023-06-20.
• Applicants must submit their applications by 2023-10-02. (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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