Statistics Center for Pediatric Type 2 Diabetes Therapy

描述（由申请人提供）： 乔治华盛顿大学生物统计学中心提议作为 协调中心（CC）的研究人员正在组装的财团， NIDDK进行儿童2型糖尿病的临床试验， 青少年。财团？的目标是开发和应用标准化的 方法，程序和措施，以进行（1）一个多中心， 多组治疗临床试验和（2）一种或多种一级预防 审判来自6 - 10个临床中心，NIDDK， CC将组成该财团，并在合作组织下进行合作。 协议机制。这个联盟将解决人们对医疗保健的关注， 研究人员和供应商对检测的稳定和有害的增加 2型糖尿病的发病率。因为知道 成人2型糖尿病微血管和大血管疾病进展，以及 了解适当治疗和管理的作用，医学科学寻求 扩大研究范围，包括治疗和预防， 调查不足和患者人数不断增加。 指导委员会由来自CC的主要调查员组成， 每个临床中心和NIDDK项目官员，将设计和开发 每个临床试验。CC将提供集中支持， 生物统计咨询：制定方案，手册， 程序、数据收集表和随机化程序;实施 数据管理系统，包括数据质量评估;中期分析 方案性能、患者安全性和治疗有效性;以及最终 与临床研究机构合作分析结果以供发表 investigators. CC将建立一个安全的加密和密码保护 研究人员网站，以加强研究的开发，分发和使用 证件 我们已经组建了一个协调中心工作人员和顾问团队， 在主要糖尿病研究工作中建立了证书和经验， 包括糖尿病控制和并发症试验和糖尿病 预防方案。

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.