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

描述（由申请人提供）： 该应用程序将成为杀微生物剂试验网络（MTN）的统计和数据管理中心（SDMC），是构成MTN领导小组的三个应用程序之一。MTN的科学议程完全侧重于RFA的优先事项4：“杀微生物剂。“本申请描述了艾滋病毒/艾滋病研究与预防统计中心（SCHARP）将如何实现RFA的目标，以（1）为网络临床试验/研究的设计，实施，分析和出版提供统计领导;（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，研究结果的处理和检索;（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）促进跨网络开发通用数据元素和数据接口的工作。 SCHARP在全球艾滋病毒疫苗和预防研究的设计、实施和分析方面拥有丰富的经验。因此，我们建议用于数据收集、管理、监测和分析的系统均经过良好测试，并符合ICH指南。SCHARP统计学家还将开发和部署新的统计方法，以提高拟议的杀微生物剂试验计划的效率和严谨性。 艾滋病毒/艾滋病流行病继续在世界几乎所有区域蔓延，2003年约有480万新感染者（艾滋病规划署《2004年全球艾滋病流行病报告》）。虽然找到一种疫苗来防止感染和/或疾病进展是公共卫生的优先事项，但人们认识到，这一目标可能需要数年时间才能实现。因此，必须找到其他类型的有效预防措施。只有通过最高科学和监管标准的临床试验才能实现这一目标。

DESCRIPTION (Provided by applicant): This application to be the Statistical and Data Management Center (SDMC) for the Microbicide Trials Network (MTN) is one of three applications comprising the Leadership Group of the MTN. The MTN scientific agenda focuses exclusively on RFA priority number 4: "Microbicides." 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, management, 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 microbicide 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.