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

杀微生物剂试验网络（MTN）正在按计划完成评估 在当前项目中，青少年、孕妇和哺乳期妇女使用达匹韦林阴道环 期不幸的是，由于COVID-19相关的研究中断，这项工作被推迟 活动为了解决这些延迟，MTN统计和数据管理中心（MTN SDMC） 请求将资金延长一年（UM 1AI 068615）以支持这些关键临床试验以及 完成对因COVID-19而中断的已完成试验的分析 疫情通过这次延期，MTN SDMC将继续支持开发一个安全和 通过以下方式预防艾滋病毒有效杀微生物剂：1.确保收集完整、高质量的数据， 提供最先进的安全数据管理系统，并根据最佳数据和临床 管理实践。2.在整个方案中提供统计、领导和支持 开发和实施过程，包括研究设计、监测、分析和报告。 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， 包括达匹韦林阴道环的研究。从事MTN的教师的科学领导 SDMC将确保MTN试验的设计旨在为以下最紧迫的问题获得可靠的答案： 杀微生物剂的发展。我们的数据收集、管理、监控和分析系统 经过充分测试，符合ICH指导原则。我们将及时支持领导小组， 在整个随访至研究完成期间准确报告MTN研究。我们将继续支持 MTN LC程序通过协调标本和检测结果，并与统计分析和 方法开发MTN SDMC统计人员将开发和部署统计方法， 提高拟议的杀微生物剂试验计划的效率和严谨性。

The Microbicide Trials Network (MTN) was on track to complete crucial studies assessing the safety of the dapivirine vaginal ring in adolescents, pregnant women and breastfeeding women within the current project period. Unfortunately, this work is being delayed as a result of the COVID-19 associated disruption of study activities. To address these delays, the MTN Statistical and Data Management Center (MTN SDMC) is requesting a one-year extension of funding (UM1AI068615) to support these critical clinical trials as well as for the completion of the analyses of completed trials which have been interrupted due to the COVID-19 epidemic. Through this extension, the MTN SDMC will continue to support the development of a safe and effective microbicide for HIV prevention by: 1. Ensuring 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. Providing statistical and leadership and support throughout the protocol development and implementation process, including study design, monitoring and analysis and reporting. The MTN SDMC has extensive experience in the design, conduct and analysis of HIV prevention studies, including studies of the dapivirine vaginal ring. 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. 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. MTN SDMC statisticians will develop and deploy statistical methodologies to increase the efficiency and rigor of the proposed program of microbicide trials.