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

本申请继续作为艾滋病毒预防统计和数据管理中心（SDMC） 试验网络（HPTN）是组成HPTN领导小组的三个应用程序之一。的 HPTN的科学议程完全集中在RFA优先事项6：“预防艾滋病毒感染。“这 应用程序描述了艾滋病毒/艾滋病研究与预防统计中心（SCHARP）将如何 实现RFA的目标，以（1）为设计，执行，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）提供数据- 重点临床试验的实施和操作;以及（5）促进跨网络的努力， 开发通用数据元素和数据接口。 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， 艾滋病毒预防试验。 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）。虽然发现A 预防感染和/或疾病进展的疫苗是公共卫生的优先事项， 这个目标可能还需要几年的时间。因此，需要寻找其他类型的有效预防措施， 措施至关重要。只有通过最高科学和监管标准的临床试验， 目标要实现。

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.