NIDDK Type 1 Diabetes TrialNet Data Coordinating Center

 描述(由申请人提供)：本申请请求支持南佛罗里达大学TrialNet协调中心(TNCC)的持续运营。自2008年10月以来，南佛罗里达大学一直担任TrialNet的协调中心。TrialNet的主要目标是通过保存高风险个体和新诊断的T1糖尿病患者的胰岛素产生β细胞来预防或延迟1型糖尿病(T1 DM)的初始发病和/或进展。为了实现这一目标，TrialNet设计并实施了预防性和干预性临床试验，旨在测试可能保留剩余胰岛素分泌的治疗方法。TNCC向临床中心、参考实验室和NIDDK提供流行病学、生物统计学、操作和行政方面的专业知识和建议，包括以下任务：1)研究范围内的交流、采购和传播研究材料，以及相关活动；2)数据管理和记录维护；3)临床现场和中心实验室监测；4)数据分析；5)准备研究报告和论文以供发表；6)实施程序以评估TNCC所采用程序的管理、方法和成本效益；以及7)定期会议。这一新的应用程序提供了额外的支持，以便与新的TrialNet中心合作解决T1D风险人群的识别问题，THA可以导致试验以预防或延缓T1D风险的进展，解决在被诊断为T1D的人群中对没有症状的T1D受试者进行干预的可行性，与TrialNet生物标记物小组(BMP)合作协助设计和实施标记物研究，以更好地向TrialNet疾病发病机制的研究提供信息，为TrialNet研究和操作的通信、数据收集、编辑、处理、分析和报告提供增强和升级，包括数据质量、方案遵守和数据保密，并规定实施和升级协调从参与的临床中心和附属中心向TrialNet中心实验室和NIDDK资料库提交样本和数据的程序。

 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.