Background & Purpose

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PURPOSE

JDRF, the world’s leading non-profit organization with the mission to cure type 1 diabetes (T1D), invites applications for international TrialNet clinical centers.

BACKGROUND

Type 1 Diabetes TrialNet is a highly collaborative clinical trials network consisting of 19 North American Clinical Centers, six JDRF International TrialNet Clinical Centers (infrastructure funded by JDRF), and a US-based Data Coordinating Center. Since its establishment in 2003, TrialNet has developed and implemented a number of prevention and new onset T1D trials, as well as a natural history study – for a complete list please refer to the TrialNet website. The Network’s primary objective is to prevent T1D and stop disease progression by preserving insulin production before and after diagnosis. These goals may involve collaborations with the Immune Tolerance Network, the pharmaceutical industry, and other funders.

JDRF is committed to facilitating the clinical testing of promising agents for the prevention or delay of T1D in the pre-symptomatic setting, as well as for restoration of normoglycemia in the new onset setting. Since TrialNet’s establishment, JDRF has enabled the participation of the International TrialNet Clinical Centers in the Network through focused infrastructure support. JDRF intends to continue this approach.

The North American TrialNet Clinical Centers are administered by NIDDK under a Cooperative Agreement type mechanism. The JDRF International TrialNet Clinical Centers will be administered by JDRF in coordination with NIDDK and TrialNet. National Institutes of Health will not provide infrastructure support for the international sites. However, the NIH would provide capitated support where appropriate.

JDRF International TrialNet Clinical Centers will be integral parts of the TrialNet structure, and will be full participants in the design and execution of pilot and expanded studies of new agents to prevent or ameliorate Type 1 diabetes. International Clinical Centers will be represented on the TrialNet Steering Committee; they will provide data to the TrialNet Coordinating Center and biologic samples to the Core Laboratories. Like their North American counterparts, JDRF International TrialNet Clinical Centers may support Affiliate Sites.