Statistical and Data Management Center (SDMC): Microbicide Trials Network

描述（由申请人提供）：本申请继续作为杀微生物剂试验网络（MTN）的统计和数据管理中心（SDMC），是组成MTN领导小组的三个申请之一。为了实现RFA-AI-12-008中描述的总体科学目标，即开发安全有效的杀微生物剂预防艾滋病毒，MTN SDMC科学议程包括以下目标：根据最佳数据和临床管理实践，提供最先进的安全数据管理系统和培训，确保收集完整、高质量的数据。2. 在整个方案制定和实施过程中提供统计和流行病学方面的领导和支持，包括研究设计、监测和分析以及报告。3. 制定和实施创新的统计和流行病学方法，以提高对艾滋病毒风险、杀微生物剂如何减少这种风险以及生物和行为因素如何改变或影响这种减少的科学认识。MTN SDMC在艾滋病毒预防研究的设计、实施和分析方面拥有丰富的经验。从事MTN SDMC的教师的科学领导将确保MTN试验旨在为杀微生物剂开发中最紧迫的问题获得可靠的答案。为了帮助指导制定和测试艾滋病毒预防综合战略的复杂任务，我们将参与一个数学建模的合作项目。新的杀菌剂将通过一系列1、2和3期试验开发出来。我们的数据收集、管理、监测和分析系统都经过了良好的测试，并符合ICH指南。我们将支持领导小组及时准确地报告MTN研究，直至研究完成。我们将继续通过协调标本和分析结果，以及统计分析和方法开发来支持MTN LC计划。SCHARP统计人员将开发和部署统计方法，以提高杀微生物剂试验计划的效率和严谨性。

DESCRIPTION (provided by applicant): This application to continue as 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. To address the overall scientific goal described in RFA-AI-12-008, the development of a safe and effective microbicide for HIV prevention, the MTN SDMC scientific agenda includes the following aims: 1. Ensure the collection of complete, high quality data by providing state-of-the-art secure data management systems and training according to best data and clinical management practices. 2. Provide statistical and epidemiologic leadership and support throughout the protocol development and implementation process, including study design, monitoring and analysis and reporting. 3. Develop and implement innovative statistical and epidemiological approaches to improve the scientific understanding of HIV risk, how microbicides reduce this risk and how this reduction may be modified or influenced by biological and behavioral factors. The MTN SDMC has extensive experience in the design, conduct and analysis of HIV prevention studies. The scientific leadership of the faculty engaged in the MTN SDMC will ensure MTN trials are designed to obtain reliable answers to the most pressing questions in microbicides development. To help guide the complex task of developing and testing integrated strategies for HIV prevention, we will engage in a collaborative program of mathematical modeling. New microbicides will be developed through a sequence of Phase 1, 2 and 3 trials. Our systems for data collection, management, monitoring and analysis are all well tested and in accordance with ICH guidelines. We will support the leadership group with timely and accurate reporting of MTN studies throughout follow-up to study completion. We will continue to support the MTN LC program through coordination of specimens and assay results, and with statistical analysis and methods development. SCHARP statisticians will develop and deploy statistical methodologies to increase the efficiency and rigor of the proposed program of microbicide trials.