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

这项申请将继续作为艾滋病毒预防统计和数据管理中心(SDMC) 审判网络(HPTN)是组成HPTN领导小组的三个应用之一。这个 HPTN科学议程专门关注RFA优先事项6：“预防艾滋病毒感染”。这 申请描述艾滋病毒/艾滋病研究和预防统计中心(SCHARP)将如何 实现RFA的目标：(1)为设计、实施、分析和 出版网络临床试验/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、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)提供数据- 重点临床试验的实施和运作；以及(5)促进跨网络的努力 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 艾滋病毒预防试验。 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)。尽管找到了一个 人们认识到，预防感染和/或疾病进展的疫苗是公共卫生的优先事项 这一目标可能还需要数年时间。因此，有必要找到其他类型的有效预防措施 措施至关重要。只有通过以最高科学和监管标准进行的临床试验，才能做到这一点 目标一定要实现。

This application to continue as the Statistical and Data Management Center (SDMC) for the HIV Prevention Trials Network (HPTN) is one of three applications comprising the Leadership Group of the HPTN. The HPTN scientific agenda focuses exclusively on RFA priority number 6: "Prevention of HIV Infection." This application describes how the Statistical Center for HIV/AIDS Research & Prevention (SCHARP) will achieve the aims of the RFA to (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 HIV prevention 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). Although finding a vaccine to protect against infection and/or disease progression is a public-health priority, it is recognized that this goal may be years away. Therefore, the need for finding other types of effective prevention measures is critical. Only through clinical trials held to the highest scientific and regulatory standards will this goal be achieved.