NIDDK Type 1 Diabetes TrialNet Data Coordinating Center

 描述（由申请人提供）：本申请要求支持南佛罗里达大学TrialNet协调中心（TNCC）的持续运营。南佛罗里达大学自2008年10月以来一直担任TrialNet的协调中心。TrialNet的主要目的是通过在高风险个体和新诊断为T1 DM的个体中保留产生胰岛素的β细胞，预防或延迟1型糖尿病（T1 DM）的初始发作和/或进展。为了实现这一目标，TrialNet设计并实施了预防和干预性临床试验，旨在测试可能保留剩余胰岛素分泌的治疗方法。TNCC为临床中心、参考实验室和NIDDK提供流行病学、生物统计学、操作和管理专业知识和建议，包括以下任务：1）研究范围内的沟通、研究材料的采购和分发以及相关活动2）数据管理和记录维护; 3）临床研究中心和中心实验室监测; 4）数据分析; 5）编写研究报告和论文供出版; 6）执行程序，以评估TNCC使用的程序的管理、方法和成本效益; 7）定期会议。这一新应用程序提供了额外的支持，以解决T1 D风险人群的识别问题，与新的TrialNet HUB合作，可以导致预防或延迟T1 D风险进展的试验，解决在诊断为T1 D但没有症状的受试者人群中进行干预的可行性（“沉默”糖尿病），与TrialNet生物标志物小组（BMP）合作，协助设计和实施标志物研究，以更好地为TrialNet研究提供关于疾病发病机制的信息，为通信、数据收集、编辑、TrialNet研究和操作的处理、分析和报告，包括数据质量、方案依从性和数据保密性，并规定实施和升级程序，以协调参与临床和附属中心向TrialNet中心实验室和NIDDK储存库提交样本和数据。

 DESCRIPTION (provided by applicant): This application requests support for the continuing operations of the TrialNet Coordinating Center (TNCC) at the University of South Florida. The University of South Florida has served as the Coordinating Center for TrialNet since October, 2008. The primary objective of TrialNet is to prevent or delay initial onset and/or progression of type 1 diabetes (T1DM) by preserving insulin-producing beta cells in individuals at elevated risk and those who have been newly diagnosed with T1DM. To achieve this goal, TrialNet designs and implements prevention and interventional clinical trials intended to test treatments that may preserve remaining insulin secretion. The TNCC provides epidemiological, biostatistical, operational and administrative expertise and advice to the clinical centers, reference laboratories and the NIDDK which include the following tasks: 1) study- wide communications, procurement and dissemination of study materials, and related activities 2) data management and records maintenance; 3)clinical site and central laboratories monitoring; 4)data analyses; 5)preparation of study reports and papers for publication; 6)implementation of procedures to evaluate management, methodology, and cost-effectiveness of procedures utilized by the TNCC; and 7)periodic meetings. This new application provides additional support to address the identification of populations at risk for T1D, in collaboration with the new TrialNet HUB, tha can lead to trials to prevent or delay progression of T1D risk, address the feasibility of interventions in the population of subjects diagnosed with T1D who are absent of symptoms ("silent" diabetes), assist in the design and implementation of marker studies in collaboration with the TrialNet Biomarkers Panel (BMP) to better inform TrialNet studies on pathogenesis of the disease, provide enhancements and upgrades for communication, data collection, editing, processing, analysis, and reporting for TrialNet studies and operations including data quality, protocol adherence and data confidentiality, and provide for implementation and upgrading of procedures for coordinating submission of samples and data from the participating Clinical and Affiliate Centers to the TrialNet Central Laboratories and NIDDK Repository.