Revision to the Coordinating Center for Type 1 Diabetes TrialNet

1 型糖尿病 TrialNet 协调中心的修订

• 批准号: 10385660
• 负责人: JEFFREY P KRISCHER
• 金额: $ 1500万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-30 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10385660
• 关键词: 3-Dimensional; Address; Adherence; Award; Beta Cell; Biological; Biological Markers; Biometry; Characteristics; Clinical; Clinical Trials; Committee Members; Communication; Conduct Clinical Trials; Data; Data Analyses; Data Collection; Data Coordinating Center; Development; Diagnosis; Disease; Enrollment; Ensure; Epidemiology; Florida; Funding; Goals; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Intervention Studies; Laboratories; Leadership; Maintenance; Manuals; Methodology; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Newly Diagnosed; Paper; Pathogenesis; Patient Care; Patients; Performance; Preparation; Prevention; Procedures; Protocols documentation; Publications; Quality Control; Questionnaires; Records; Reporting; Request for Applications; Research; Research Design; Research Project Grants; Research Support; Risk; Risk Factors; Safety; Sampling; Site; Specimen; Standardization; Statistical Data Interpretation; Support System; System; Testing; Universities; Update; Visit; care costs; clinical center; clinical research site; cost effectiveness; data management; data quality; design; diabetes risk; follow-up; insight; insulin dependent diabetes mellitus onset; insulin secretion; novel therapeutics; operation; payment; pre-clinical; preservation; prevent; recruit; repository; research study; response; screening

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 (T1D) 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. This application provides support for the design and conduct of prevention and recent onset trials. It provides for continued support for TrialNet and the many ongoing projects focused on the identification of individuals at risk and their enrollment on TrialNet studies.

项目总结/摘要 该应用程序请求支持审判网协调中心的持续运作。 中心（TNCC）在南佛罗里达大学。南佛罗里达大学曾担任 自2008年10月以来，审判网协调中心。TrialNet的主要目标是 预防或延迟1型糖尿病（T1D）的初始发作和/或进展，通过保留胰岛素- 在高风险个体和新诊断的人中产生β细胞 关于T1DM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的治疗 最近诊断的个体（新发）分泌。TNCC提供流行病学， 生物统计学、操作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、采购和分发学习材料以及相关活动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 评价程序的管理、方法和成本效益的程序 由TNCC使用。该应用程序为以下方面的设计和实施提供支持： 预防和最近的发病试验。它规定继续支持审判网和许多 正在进行的项目侧重于查明有风险的个人， TrialNet研究。