Limited Competition for the Continuation of the Coordinating Center for Type 1 Diabetes TrialNet (U01 Clinical Trial Required) | RFA DK 18 509

Opportunity Information: Apply for RFA DK 18 509

This grant opportunity, titled "Limited Competition for the Continuation of the Coordinating Center for Type 1 Diabetes TrialNet (U01 Clinical Trial Required)," is a National Institutes of Health (NIH) cooperative agreement that funds the ongoing leadership and operational backbone of the Type 1 Diabetes TrialNet network. It is a limited competition, meaning the NIH is specifically inviting an application from the current Program Director/Principal Investigator who is already running the TrialNet Coordinating Center (TNCC). The purpose is continuity: keeping a complex, multi-site research network functioning smoothly while it screens individuals at risk for type 1 diabetes (T1D) and runs intervention studies designed to delay disease onset or preserve insulin-producing beta cell function.

At the center of the work is TrialNet's large-scale screening and monitoring effort focused on relatives of people with T1D, since family members have elevated risk. The coordinating center is expected to oversee processes that identify, enroll, and follow these participants over time, including monitoring for markers of developing autoimmune diabetes and determining eligibility for prevention or early-intervention trials. The overall aim is to move people into studies at the earliest stages possible, when interventions may have the best chance to preserve remaining beta cell function or slow progression toward clinical diabetes.

Beyond screening, the TNCC is responsible for enabling the design, conduct, and continuation of TrialNet intervention studies in two key groups: (1) individuals in early pre-clinical stages of T1D (often characterized by immunologic markers and dysglycemia before a formal diagnosis), and (2) individuals with new-onset T1D. Which specific studies move forward is guided by the TrialNet Steering Committee, but the TNCC provides the practical infrastructure that turns those scientific decisions into workable, compliant clinical trials. Because the FOA is labeled "Clinical Trial Required," the coordinating center's responsibilities explicitly include supporting clinical trial activity rather than only observational or administrative functions.

A major expectation in this announcement is that the TNCC will support a broad portfolio of TrialNet research projects that may be at very different points in the pipeline, including planning, active enrollment, intervention delivery, follow-up, closeout, and analysis. That includes coordinating day-to-day trial operations across multiple sites, aligning procedures so data are comparable, managing protocol amendments, tracking milestones, and ensuring the overall network can execute studies reliably and consistently.

Data and biospecimen oversight is another core function. The TNCC is expected to provide comprehensive data and sample management services, including standardized acquisition procedures, quality control processes, and systems for dissemination. The FOA emphasizes public accessibility, signaling that the coordinating center must not only collect and curate information and samples but also manage them in a way that supports sharing and broader scientific use, consistent with NIH expectations for transparency, reuse, and responsible stewardship.

Financial and site-management responsibilities are also built into the coordinating center role. The TNCC will provide capitated payments to Clinical Centers and Affiliate Sites based on TrialNet-related activities, essentially functioning as the hub that distributes operational funding tied to work performed across the network. This requires well-defined activity-based payment structures, tracking and reconciliation, and consistent communication so that participating sites are supported and incentivized to meet enrollment and performance goals.

Another distinctive requirement is that the TNCC must issue a Request for Proposals (RFP) to select Clinical Centers that will conduct TrialNet clinical studies. In practice, this means the coordinating center is not only managing existing sites but also running a structured selection process to identify and engage capable clinical centers, ensuring adequate geographic reach, participant access, and operational capacity for TrialNet studies. This selection function reinforces that the award supports a network-level infrastructure, not a single stand-alone trial.

From an administrative standpoint, the opportunity is listed as RFA-DK-18-509 under the U.S. Department of Health and Human Services, NIH, and uses a cooperative agreement mechanism (U01). A cooperative agreement typically indicates substantial NIH programmatic involvement, with active collaboration between the awardee and NIH staff on planning, oversight, and performance. The activity category is health, and the CFDA number is 93.847. Eligibility is limited to public and state-controlled institutions of higher education, consistent with the fact that the coordinating center is housed within an academic-style institution capable of managing large clinical research networks.

The funding profile underscores that this is a major, centralized award. The FOA anticipated a single award (ExpectedAwards: 1) with an award ceiling of $15,000,000. The opportunity was created on January 9, 2019, with an original closing date of March 21, 2019. Overall, the grant is best understood as continued support for the operational engine of TrialNet: keeping screening and monitoring running at scale, coordinating complex multi-site intervention trials in at-risk and newly diagnosed individuals, managing high-quality data and biospecimens for broad use, and sustaining a network of clinical sites through structured selection and activity-based payments.

• The Department of Health and Human Services, National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of the Coordinating Center for Type 1 Diabetes TrialNet (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on Jan 09, 2019.
• Applicants must submit their applications by Mar 21, 2019. (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 $15,000,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: Public and State controlled institutions of higher education.

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