The University of Florida, a founding member of the DPT-1 and the internationally constituted diabetes trial network (Type 1 Diabetes TrialNet), has made significant and important contributions to TrialNet and type 1 diabetes (T1D), where it participates as one of the top performing Clinical Centers. The primary goal of TrialNet is to prevent and/or delay the development of T1D in persons at risk for the disease by testing interventions targeted at decreasing ?-cell destruction and/or enhancing ?-cell survival. The University of Florida seeks to continue serving as a Clinical Center as part of the TrialNet network. The NIH TrialNet RFA intends to continue providing support for highly productive centers by funding the necessary infrastructure that would enable screening large numbers of T1D relatives so as to identify those at risk of clinical disease. Continuing TrialNet membership would enable our established and highly successful University of Florida Clinical Center and its strong Affiliate network to continue supporting subject recruitment into studies, enhancing trial performance, subject retention, and follow-up. Indeed, our Center is poised to continue the quest for the future prevention and reversal of T1D through its outstanding environment and innovative investigators with proven approaches, each dedicated to identifying a means to prevent/cure the disease as well as to enhance recruitment and retention for T1D clinical trials. In responding to this RFA, this application describes: 1) Unique strengths and contributions of the institution to TrialNet and the T1D field;2) Ongoing and novel strategies to identify and maintain an active Affiliate network;3) Recruitment, outreach, and collaboration plans;4) Strategies to enhancing cost efficiency;5) Performance monitoring;6) Consideration of federated IRB;7) Development of future T1D clinical researchers;and 8) Potential opportunities and challenges for the prevention of T1D currently and over the next 5 years.
Each year, over 20,000 children and adolescents, as well as a similar number of adults, are diagnosed in the U.S. with type 1 diabetes (T1D). The disease represents a tremendous burden for the both two million Americans having the disorder and society as well, given significant short- and long term complications notwithstanding the tremendous financial costs. The NIH-supported T1D TrialNet Clinical Network is designed to disrupt this cycle through recruitment of non-diabetic, but at-risk individuals. This, for the purpose of undertaking therapies aimed at preventing or delaying the development this disease.
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