Statistics Center for Pediatric Type 2 Diabetes Therapy

儿科 2 型糖尿病治疗统计中心

• 批准号: 6804368
• 负责人: KATHRYN HIRST
• 金额: $ 16.56万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2009-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6804368
• 关键词: adolescence (12-20); cooperative study; data management; diabetes mellitus therapy; disease /disorder prevention /control; health science research analysis /evaluation; human therapy evaluation; informatics; middle childhood (6-11); noninsulin dependent diabetes mellitus; patient oriented research; pediatrics; statistical service /center; statistics /biometry; therapy compliance

DESCRIPTION (provided by applicant): The George Washington University Biostatistics Center proposes to serve as the Coordinating Center (CC) for the consortium of investigators being assembled by the NIDDK to conduct clinical trials of type 2 diabetes in children and adolescents. The consortium?s objective is to develop and apply standardized methods, procedures, and measures to the conduct of (1) one multi-center, multi-arm clinical trial of treatment and (2) one or more primary prevention trials. Researchers and investigators from 6-10 clinical centers, the NIDDK, and the CC will comprise the consortium and collaborate under a cooperative agreement mechanism. This consortium will address the concern of health care researchers and providers over the steady and pernicious increase in detection of type 2 diabetes in youth both here and abroad. Knowing the consequences of type 2 diabetes in adults for micro-and macro-vascular disease progression, and knowing the role of adequate treatment and management, medical science seeks to broaden the scope of research to include treatment and prevention in this under-investigated and growing population of patients. The Steering Committee, composed of the Principal Investigators from the CC and each clinical center and the NIDDK project officer, will design and develop each of the clinical trials. The CC will provide centralized support and biostatistical consultation in: the development of protocols, manuals of procedures, data collection forms, and randomization procedures; implementation of a data management system including data quality assessment; interim analysis of protocol performance, patient safety, and treatment efficacy; and final analysis for publication of results in collaboration with the clinical investigators. The CC will establish a secure encrypted and password protected web site for study staff to enhance development, distribution, and use of study documents. We have assembled a team of coordinating center staff and consultants with established credentials and experience in major diabetes research efforts, including the Diabetes Control and Complications Trial and the Diabetes Prevention Program.

描述(由申请人提供)： 乔治华盛顿大学生物统计中心建议作为 正在组建的调查财团的协调中心(CC) NIDDK将进行儿童2型糖尿病的临床试验和 青少年。S联合体的目标是开发和应用标准化 实施(1)一个多中心的方法、程序和措施 治疗的多臂临床试验和(2)一个或多个一级预防 审判。来自6-10个临床中心的研究人员和研究人员，NIDDK， 而CC将由联合体组成并在合作社下进行合作 协议机制。这个联合体将解决医疗保健方面的关切 研究人员和提供者对检测的稳步和有害的增加 在国内外的年轻人中，2型糖尿病的发病率很高。知道这样做的后果 成人2型糖尿病的微血管和大血管疾病进展，以及 知道适当的治疗和管理的作用，医学科学试图 扩大研究范围，将治疗和预防纳入其中 调查不足，患者人数不断增加。 由消委会首席调查员和 每个临床中心和NIDDK项目官员将设计和开发 每一项临床试验。协调中心将提供集中支持和 生物统计学咨询：方案的制定，手册 程序、数据收集表格和随机化程序；实施 包括数据质量评估的数据管理系统.中期分析 方案性能、患者安全性和治疗效果；以及最终 与临床医学合作发表成果的分析 调查人员。CC将建立一个安全的加密和密码保护系统 为学习人员提供的网站，以加强学习的开发、分发和使用 文件。 我们已经组建了一个协调中心的工作人员和顾问团队， 在主要的糖尿病研究工作中确立了资历和经验， 包括糖尿病控制和并发症试验和糖尿病 预防计划。