Data Coordinating Center for the Network of Excellence in Neuroscience Clinical Trials (NEXT - DCC) (U01 Clinical Trial Not Allowed) | RFA NS 22 030

Opportunity Information: Apply for RFA NS 22 030

The National Institute of Neurological Disorders and Stroke (NINDS) is seeking applications for a Data Coordinating Center (DCC) to support the Network for Excellence in Neuroscience Clinical Trials (NEXT). This opportunity is a reissue of an earlier solicitation (RFA-NS-11-010) and is published as RFA-NS-22-030. The award mechanism is a U01 cooperative agreement, meaning the project will be carried out with substantial scientific and programmatic involvement from NIH staff. Although the network focuses on clinical research, this particular FOA is labeled "Clinical Trial Not Allowed," which signals that the applicant for the DCC is not being funded to run its own independent clinical trial as the primary activity; instead, the DCC provides the centralized data and operational infrastructure that enables multiple trials and clinical studies conducted across the broader NEXT network.

The NEXT program itself is designed as a flexible, disease-agnostic neuroscience clinical research network capable of launching and running multiple, scientifically rigorous exploratory studies. The intent is to efficiently evaluate promising therapies emerging from academia, foundations, or industry, with an emphasis on studies that can move the field toward definitive trials. The FOA highlights examples such as Phase 2 clinical trials and clinical research efforts that validate biomarkers and clinical outcome measures so that later-stage trials can be designed with stronger endpoints and better patient stratification. The network is meant to handle studies in neurological disorders affecting adult and/or pediatric populations, and it is structured so it can rapidly assemble the right specialist investigators when a disease-specific opportunity arises rather than being locked into a single disorder area.

Within that larger structure, the DCC is the backbone for data and coordination functions that let a multi-site network run efficiently and consistently. While the FOA text provided does not list every task explicitly, a NEXT DCC role typically includes building and maintaining standardized data systems; developing common data elements and harmonized case report forms; managing data capture, quality control, and audit trails; supporting randomization and other trial operations where appropriate; producing data reports for monitoring and decision-making; ensuring secure handling and sharing of data; and enabling timely access to well-curated datasets. Because NEXT aims for a robust and accessible infrastructure, the DCC is expected to help standardize processes across different neurological studies so that protocols can be developed and implemented quickly without reinventing the operational and data framework each time.

This DCC competition is only one piece of the overall NEXT ecosystem. NINDS is also soliciting, through separate funding announcements, applications for the Clinical Sites and for the Clinical Coordinating Center. In practice, that division of roles is meant to separate the "where and with whom the studies are conducted" (clinical sites), the "operational leadership and study management" (clinical coordinating center), and the "data, systems, and cross-study standardization" (data coordinating center). Applicants interested in NEXT should understand how the DCC will interface with these other components to support multiple concurrent or sequential studies, each potentially involving different disorders, endpoints, and biomarker strategies.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include 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 governments; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other unspecified eligible entities. The FOA also explicitly notes categories 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 (AANAPISISs), along with faith-based or community-based organizations and eligible federal agencies, emphasizing the program's openness to a wide range of domestic organizational types that can credibly deliver large-scale coordinating infrastructure.

Foreign participation is specifically restricted. 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 funded components of the work must be U.S.-based, which is consistent with NIH requirements for many cooperative agreements involving centralized infrastructure and governance.

From the administrative details provided, the sponsoring agency is the National Institutes of Health (NIH), with the relevant program housed in NINDS, and the CFDA number listed is 93.853. The opportunity category is discretionary, and the activity category is health. The original closing date shown is November 21, 2022, indicating the window for submission tied to this posting. The award ceiling listed is $1,300,000, which sets an upper bound on the funding level for an individual award under this announcement, though actual budgets typically depend on the proposed scope, network expectations, and negotiations under the cooperative agreement structure. The central takeaway is that NINDS is investing in a dedicated, standardized data coordinating hub so that NEXT can run multiple exploratory neuroscience clinical studies more rapidly, consistently, and with higher-quality data than would be feasible through isolated, one-off trial infrastructures.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Data Coordinating Center for the Network of Excellence in Neuroscience Clinical Trials (NEXT - DCC) (U01 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): 93.853.
• This funding opportunity was created on 2022-09-20.
• Applicants must submit their applications by 2022-11-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,300,000.00 in funding.
• 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 NS 22 030

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