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中心提议充当 协调中心（CC），负责由以下机构组建的调查人员联盟 NIDDK 开展儿童 2 型糖尿病临床试验 青少年。该联盟的目标是开发和应用标准化 进行（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) 一项或多项一级预防 试验。来自 6-10 个临床中心、NIDDK 的研究人员和调查员， CC 将组成财团并在合作社下进行合作 协议机制。该联盟将解决医疗保健问题 研究人员和提供者对检测数量的稳定和有害增加 国内外青少年 2 型糖尿病的发病率。知道后果 成人 2 型糖尿病的微血管和大血管疾病进展，以及 了解充分治疗和管理的作用后，医学科学致力于 扩大研究范围，将治疗和预防纳入其中 调查不足且患者人数不断增加。 指导委员会由CC和CC的主要研究员组成 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。 CC将提供集中支持和 生物统计咨询：制定方案、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 方案执行、患者安全和治疗效果；和最终的 与临床合作分析结果的发表 调查人员。 CC将建立安全加密和密码保护 供研究人员加强研究的开发、分发和使用的网站 文件。 我们组建了一支由协调中心工作人员和顾问组成的团队 在主要糖尿病研究工作中建立了资历和经验， 包括糖尿病控制和并发症试验以及糖尿病 预防计划。

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.