Limited Competition: Data Coordinating Center for Type 1 Diabetes TrialNet (UC4) | RFA DK 17 507

Opportunity Information: Apply for RFA DK 17 507

The Limited Competition: Data Coordinating Center for Type 1 Diabetes TrialNet (UC4) funding opportunity (RFA-DK-17-507) is an NIH cooperative agreement designed to continue and strengthen the central data and trial-management infrastructure for the Type 1 Diabetes TrialNet clinical research network. It is a limited competition announcement, meaning it is not broadly open to new coordinating centers; instead, it specifically invites an application from the Program Director/Principal Investigator of the Data Coordinating Center (DCC) that is already supporting TrialNet. The purpose is to ensure continuity of the sophisticated coordinating functions needed to run TrialNet efficiently while enabling the network to launch and execute additional clinical trials in a consistent, high-quality way.

The scientific and clinical focus of the work supported under this FOA is the design and conduct of new-onset interventional trials in people who have recently been diagnosed with type 1 diabetes. These trials, selected by the TrialNet Steering Committee, are aimed at preserving insulin-producing beta cells. In practical terms, preserving remaining beta-cell function soon after diagnosis can potentially improve glycemic control, reduce insulin requirements, and delay or lessen complications, so the DCC role is central to making sure the trials are operationally sound, statistically credible, and conducted with strong oversight across multiple sites.

Because the award mechanism is a UC4 cooperative agreement, NIH is expected to have substantial programmatic involvement compared with a standard research grant. Cooperative agreements typically involve close collaboration between the awardee and NIH staff on key elements such as protocol development, data standards, performance monitoring, and network coordination. For a network like TrialNet, which depends on harmonized procedures across many clinical sites and stakeholder groups, that cooperative structure signals a highly coordinated relationship between the DCC, the TrialNet governance (including its Steering Committee), and NIH.

The DCC supported by this opportunity would generally be expected to provide the core operational backbone for multi-site trials. While the announcement text provided is brief, a DCC in this context usually handles responsibilities such as data collection systems and database management, statistical design and analysis support, randomization, trial monitoring and reporting, quality control and assurance processes, regulatory and compliance coordination support, and timely communication of trial status and results to network leadership. The DCC is also commonly responsible for ensuring consistent data definitions and standards across studies so results can be compared or combined appropriately, and for supporting the day-to-day mechanics of running trials across a large consortium.

Eligibility is constrained. The listed eligible applicant type includes public and state-controlled institutions of higher education, and the FOA explicitly states that non-U.S. (foreign) institutions are not eligible to apply and that non-U.S. components of U.S. organizations are not eligible to apply. At the same time, it allows “foreign components” as defined by the NIH Grants Policy Statement, which typically means certain discrete project elements may occur outside the U.S. under specific conditions and approvals, even though the applicant organization itself must be U.S.-based and eligible. This structure is consistent with maintaining centralized U.S.-based coordination while still permitting limited international involvement when scientifically justified and compliant with NIH policy.

Key administrative details include an original closing date of July 14, 2017, and a creation date of April 21, 2017. The sponsoring agency is the National Institutes of Health, and the activity aligns with NIH’s diabetes-related programs reflected in the CFDA numbers 93.847, 93.855, and 93.856. The opportunity category is discretionary, and the funding instrument is explicitly a cooperative agreement. The source excerpt does not specify an award ceiling or the expected number of awards, which often indicates those details were either set elsewhere in the full FOA or left flexible based on available funds and the scope of the proposed coordinating-center activities.

Overall, this FOA is best understood as an NIH effort to sustain and direct the specialized coordinating center that enables TrialNet to run complex, multi-site new-onset type 1 diabetes trials focused on preserving beta-cell function. Rather than funding a new scientific hypothesis at a single site, it funds the infrastructure, expertise, and leadership needed to reliably design, manage, and analyze network-wide trials chosen by TrialNet’s Steering Committee, under a cooperative model with active NIH involvement.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition: Data Coordinating Center for Type 1 Diabetes TrialNet (UC4)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847, 93.855, 93.856.
• This funding opportunity was created on 2017-04-21.
• Applicants must submit their applications by 2017-07-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Public and State controlled institutions of higher education.

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