Statistics Center for Pediatric Type 2 Diabetes Therapy

乔治华盛顿大学生物统计中心提议担任协调中心 (CC)由NIDDK组建的研究者联盟进行2型临床试验 儿童和青少年的糖尿病。该联盟的目标是制定和应用标准化的 方法，程序和措施，以进行（1）一个多中心，多臂临床试验， （2）一个或多个初级预防试验。来自6-10个临床的研究人员和调查人员 中心、NIDDK和CC将组成联合体，并在一个合作组织下进行合作 协议机制。该联盟将解决卫生保健研究人员和提供者的关切， 在国内外的年轻人中发现2型糖尿病的稳定和有害的增长。 了解成人2型糖尿病对微血管和大血管疾病进展的影响， 认识到适当治疗和管理的作用，医学科学寻求扩大治疗范围， 研究，包括治疗和预防，在这个调查不足和不断增长的患者群体。 指导委员会，由CC和各临床中心的主要研究者组成 和NIDDK项目官员，将设计和开发每一个临床试验。CC将提供 在以下方面提供集中支持和生物统计咨询：方案制定;程序手册， 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;方案性能、患者安全性和治疗的中期分析， 疗效;以及与临床研究者合作发表结果的最终分析。的CC 将为研究人员建立一个安全加密和密码保护的网站，以促进开发， 分发和使用研究文件。 我们已经组建了一个由协调中心工作人员和顾问组成的团队， 主要糖尿病研究工作的经验，包括糖尿病控制和并发症试验， 糖尿病预防计划。

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.