Data Coordinating Center for Type 1 Diabetes TrialNet (UC4)USF: TrialNet UC4-3

1 型糖尿病数据协调中心 TrialNet (UC4)USF：TrialNet UC4-3

基本信息

批准号：
9506924
负责人：
JEFFREY P KRISCHER
金额：
$ 4264.62万
依托单位：
UNIVERSITY OF SOUTH FLORIDA
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-22 至 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9506924
关键词：
Address Adherence Award Beta Cell Biological Biological Markers Biometry Characteristics Clinical Clinical Trials Committee Members Communication Conduct Clinical Trials Contracts Data Data Analyses Data Collection Data Coordinating Center Data Quality Development Diabetes Mellitus Diabetes prevention Diagnosis Disease Enrollment Ensure Epidemiology Florida Funding Future Goals Grant Individual Insulin Insulin-Dependent Diabetes Mellitus Intervention Intervention Studies Investigation Laboratories Lead Maintenance Manuals Methodology Monitor National Institute of Diabetes and Digestive and Kidney Diseases Newly Diagnosed Paper Pathogenesis Periodicity Population Preparation Prevention Preventive Intervention Procedures Process Protocols documentation Publications Quality Control Questionnaires Records Recruitment Activity Reporting Request for Applications Research Risk Risk Assessment Risk Factors Safety Sampling Site Specimen Statistical Data Interpretation System Testing Universities Update clinical research site cost effectiveness data management design diabetes risk follow-up innovation insight insulin dependent diabetes mellitus onset insulin secretion meetings novel strategies novel therapeutics operation prevent protocol development repository research study responders and non-responders response symposium trial design

项目摘要

Project Summary/Abstract 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 in recently diagnosed individuals (new-onsets). 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 focus on the design and conduct of new-onset trials (as selected by the TrialNet Steering Committee) and associated mechanistic studies that can lead to targeted trials to prevent or delay progression of T1D, 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.

项目概要/摘要此申请请求支持 TrialNet 协调的持续运营南佛罗里达大学中心 (TNCC)。南佛罗里达大学曾担任自 2008 年 10 月起担任 TrialNet 协调中心。TrialNet 的主要目标是通过保留来预防或延迟 1 型糖尿病 (T1DM) 的初始发作和/或进展高风险个体和新近患病个体中产生胰岛素的β细胞诊断患有 T1DM。为了实现这一目标，TrialNet 设计并实施了预防和旨在测试可保留剩余胰岛素的治疗方法的介入临床试验最近诊断的个体（新发病例）的分泌。 TNCC 提供流行病学、生物统计、运营和管理专业知识以及对临床中心的建议，参考实验室和 NIDDK 包括以下任务：1) 研究范围交流、采购和传播学习材料以及相关活动 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）准备发表研究报告和论文； 6）实施评估程序的管理、方法和成本效益的程序由 TNCC 使用； 7) 定期会议。这个新应用程序提供了额外的支持专注于新发试验的设计和实施（由 TrialNet 指导委员会选择）委员会）和相关的机制研究，可以导致有针对性的试验来预防或延缓 T1D 的进展，提供通信、数据的增强和升级 TrialNet 研究和运营的收集、编辑、处理、分析和报告包括数据质量、协议遵守和数据机密性，并提供实施和升级协调样品提交和从参与临床和附属中心到 TrialNet 中央实验室的数据和 NIDDK 存储库。