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

艾滋病毒/艾滋病临床试验网络的领导；

基本信息

批准号：
8289674
负责人：
Elizabeth Renata Brown
金额：
$ 363.74万
依托单位：
FRED HUTCHINSON CANCER RESEARCH CENTER
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-06-29 至 2013-12-31
项目状态：
已结题

项目摘要

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.

描述（由申请人提供）：该应用程序是Microbicide试验网络（MTN）的统计和数据管理中心（SDMC）是包括MTN领导力小组的三个应用程序之一。 MTN科学议程仅关注RFA优先级4：“微生物剂”。该申请描述了艾滋病毒/艾滋病研究与预防统计中心（SCHARP）如何实现RFA的目标（1）为网络临床试验/研究的设计，行为，分析和出版的设计，行为，分析和发布；（2）提供中央数据管理能力，包括随机化，数据集和案例报告表格设计，中央存储，安全性，处理和研究结果的检索；（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；（5）在开发常见的数据元素和数据接口方面有助于跨网络工作。 Scharp在全球HIV疫苗和预防研究的设计，行为和分析方面具有丰富的经验。因此，我们建议用于数据收集，管理，监视和分析的系统都经过了很好的测试，并且按照ICH指南进行了很好的测试。 Scharp统计学家还将开发和部署新颖的统计方法，以提高拟议的杀菌剂试验计划的效率和严格性。艾滋病毒/艾滋病的流行在世界上几乎所有地区都在扩大，2003年大约有480万新的新感染（UNAIDS 2004年全球艾滋病流行报告）。尽管找到一种防止感染和/或疾病进展的疫苗是公共卫生的优先事项，但人们认识到，这一目标可能还要多年。因此，需要寻找其他类型的有效预防措施的需求至关重要。只有通过达到最高科学和法规标准的临床试验才能实现这一目标。