NIDDK Type 1 Diabetes TrialNet Data Coordinating Center

点击翻译按钮获取中文摘要

 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.