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

这项申请将继续作为艾滋病毒疫苗统计和数据管理中心(SDMC) 试验网络(HVTN)是由该网络领导小组组成的三个应用之一。这个 HVTN科学议程专门关注RFA优先事项1：“疫苗研究和 这份申请描述了艾滋病毒/艾滋病研究和预防统计中心如何 (SCARP)将实现RFA的目标：(1)为设计、实施、 分析和发布网络临床试验/研究；(2)提供中央数据管理能力 这包括随机化、数据集和病例报告表设计、中央存储、安全、处理和 检索研究结果；(3)在整个网络中提供数据管理和协议培训；(4) 提供以数据为重点的临床试验实施和操作；以及(5)促进跨网络 努力开发通用数据元素和数据接口。 沙普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 所有的分析都经过了良好的测试，并符合非物质文化遗产指南。沙普统计学家也将开发 并部署新的统计方法，以提高拟议方案的效率和严谨性 HLV疫苗试验。 艾滋病毒/艾滋病疫情在世界几乎所有区域继续扩大，约有4.8人 2003年新增感染者100万人(艾滋病规划署2004年全球艾滋病流行报告)。寻找一种安全、有效的 保护人们免受感染和/或疾病进展的疫苗是一种国际公共疫苗- 健康优先。只有通过以最高科学和监管标准进行的临床试验，才能实现这一目标 才能实现。

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.