Leadership for HIV/AIDS Clinical Trials Networks; HIV Vaccine Trials Network

本申请继续作为HIV疫苗的统计和数据管理中心（SDMC） 试验网络（HVTN）是组成HVTN领导小组的三个应用程序之一。的 HVTN科学议程专注于RFA优先事项1：“疫苗研究和 发展“这个应用程序描述了艾滋病毒/艾滋病研究和预防统计中心如何 （SCHARP）将实现RFA的目标：（1）为设计，实施， 分析和发表网络临床试验/研究;（2）提供中央数据管理能力 包括随机化、数据集和病例报告表设计、中央存储、安全性、处理和 检索研究结果;（3）在整个网络中提供数据管理和方案培训;（4） 提供以数据为中心的临床试验实施和操作;以及（5）促进跨网络 努力开发共同数据要素和数据接口。 SCHARP在全球艾滋病毒疫苗的设计、实施和分析方面拥有丰富的经验， 预防研究。因此，我们建议用于数据收集、管理、监控和 所有分析均经过充分测试，并符合ICH指南。SCHARP统计人员还将开发 并部署新的统计方法，以提高拟议计划的效率和严谨性， HIV疫苗试验 艾滋病毒/艾滋病流行病继续在世界几乎所有区域蔓延，约有4.8 2003年新感染艾滋病的人数为100万（艾滋病规划署2004年全球艾滋病流行情况报告）。找到一个安全有效的 将保护人们免受感染和/或疾病进展的疫苗是国际公众- 健康优先。只有通过最高科学和监管标准的临床试验， 实现。

This application to continue as the Statistical and Data Management Center (SDMC) for the HIV Vaccine Trials Network (HVTN) is one of three applications comprising the Leadership Group of the HVTN. The HVTN scientific agenda focuses exclusively on RFA priority number 1: 'Vaccine Researchand Development." This application describes howthe Statistical Center for HIV/AIDS Research& Prevention (SCHARP) will achieve the aims of the RFAto (1) provide statistical leadership for the design, conduct, analysis and publication of Network clinical trials/studies; (2) provide central data management capability that includes randomization, data set and case report form design, central storage, security, processing and retrieval of study results; (3) provide data management and protocol training throughout the Network; (4) provide data-focused clinical trials implementation, and operation; and (5) contribute to cross-Network efforts in developing common data elements and data interfaces. SCHARP has extensive experience in the design, conduct and analysis of global HIV vaccine and prevention studies. Thus, the systems we propose to use for data collection, managment, monitoring, and analysis are all well tested and in accordance with ICH guidelines. SCHARP statisticians will also develop and deploy novel statistical methodologies to increase the efficiency and rigor of the proposed program of HlV vaccine trials. The HIV/AIDS epidemic continues to expand in almost all regions of the world, with approximately 4.8 million new infections in 2003 (UNAIDS 2004 Report on the Global AIDS Epidemic). Finding a safe, effective vaccine that will protect persons against infection and/or disease progression is an international public- health priority. Only through clinical trials held to the highest scientific and regulatory standards willthis goal be achieved.