Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required) | PAR 24 087

Opportunity Information: Apply for PAR 24 087

The National Center for Complementary and Integrative Health (NCCIH), part of the National Institutes of Health (NIH), is soliciting applications for a Data Coordinating Center (DCC) to support an investigator-initiated, multi-site clinical trial focused on mind and body interventions. This opportunity uses the U24 cooperative agreement mechanism, which typically means the awardee will work closely with NIH staff during planning and execution rather than operating with minimal federal involvement. The funding announcement is PAR-24-087, and it is specifically designed for Phase III (and later) multi-site clinical trials that align with NCCIHs mission and are considered a high priority by the Center. Applicants are encouraged to review NCCIHs strategic vision and research priorities on the NCCIH website and to contact the relevant NCCIH scientific/research program staff before submitting, since program fit and priority are central to whether an application is competitive.

A key feature of this opportunity is that the DCC application cannot be submitted as a stand-alone project. It must be paired with, and tailored to, a companion Clinical Coordinating Center (CCC) application for the same trial. The companion trial application is submitted under PAR-21-243, and NCCIH expects the DCC and CCC applications to be submitted at the same time for joint consideration. In practical terms, the CCC typically leads the clinical operations (sites, recruitment, intervention delivery, trial conduct), while the DCC provides the backbone for coordination, data, and statistics across all sites. NCCIH is looking for an integrated trial team where the DCC is clearly designed around the specific scientific aims, operational realities, outcomes, and design features of the companion trial.

The purpose of the DCC is to provide a comprehensive plan for overall project coordination and for administrative, data management, and biostatistical support. That generally includes setting up and maintaining the trials data systems, developing data standards and workflows, supporting randomization and allocation processes when applicable, overseeing data quality control and monitoring, producing interim and final statistical analyses, and ensuring consistent implementation of protocols across sites from a data and reporting perspective. The DCC is also expected to support cross-site communication and project management functions that help keep a complex, multi-site effort on schedule and compliant, including coordination of reporting, documentation, and other trial infrastructure needs that are critical for Phase III and later-stage studies.

This NOFO includes an explicit requirement for a Plan for Enhancing Diverse Perspectives (PEDP). The PEDP is not optional; it is assessed during scientific and technical peer review, and applications that do not include it will be considered incomplete and withdrawn. The intent is to ensure that the project meaningfully incorporates diverse perspectives in ways that strengthen the science and its relevance, which may include considerations related to team composition, stakeholder engagement, study populations, recruitment approaches, site selection, and other structural choices that can affect the rigor and generalizability of the trial. NCCIH strongly encourages applicants to carefully follow the PEDP instructions and use available NIH guidance materials when preparing this plan.

Eligibility is broad and includes many domestic public and private entities, such as state, county, and local 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 that are not federally recognized; 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); and small businesses. The announcement also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, Asian American Native American Pacific Islander Serving Institutions, faith-based or community-based organizations, and eligible federal agencies, as well as U.S. territories or possessions. Foreign organizations (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components as defined in the NIH Grants Policy Statement are allowed, meaning certain discrete collaborations or elements may be permitted under NIH rules even though the applicant organization must be domestic.

From an administrative standpoint, the awarding agency is NIH, the activity category is Health, and the CFDA (now commonly referred to as the Assistance Listing) number is 93.213. The original closing date listed for this opportunity is 2024-07-16. The announcement does not specify an award ceiling or expected number of awards in the provided text, so applicants would need to consult the full NOFO for budget expectations, project period limits, and other detailed submission requirements.

Overall, this opportunity is meant for research teams that are ready to run a large, later-phase, multi-site clinical trial of a mind and body intervention and that need a dedicated, expert DCC to deliver the coordination, data infrastructure, and statistical leadership required for a rigorous trial. The central message is that NCCIH is funding a paired structure: a CCC to run the trial and a DCC to ensure the data, analytics, and cross-site coordination are robust, compliant, and scientifically credible, with an added emphasis on embedding diverse perspectives through the required PEDP.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Data Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213.
• This funding opportunity was created on 2023-12-20.
• Applicants must submit their applications by 2024-07-16. (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 24 087

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