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该药物安全性的关键研究

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.