Leadership and Operations Center (LOC): Microbicide Trials Network

描述：组成部分1(概述)：MTN领导小组由领导运营中心(LOC)、实验室中心(LC)和统计和数据管理中心(SDMC)组成，每个中心都提交了主题相关但独立的申请。LOC由两名首席调查人员领导：莎伦·希利尔博士和伊恩·麦高恩博士，他们都在匹兹堡的马吉妇女研究所工作，各自提供不同但互补的专业知识。Hillier博士是MTN阴道杀菌剂开发和女性生殖健康的主要领导；McGowan博士领导MTN直肠杀菌剂研究议程和粘膜免疫学项目。 LOC还包括运营支持核心(CATS)、华盛顿大学核心(CELUM)、LC(Dezzutti)和SDMC(Brown)的PI，它们共同工作，并与网络附属的临床试验单位/站点一起实施研究议程。LOC得到了3个工作组--生物医学、行为研究和社区--和3个网络委员会的支持：研究监测、网络评估和手稿开发。私营部门主管机构以及各工作组和网络委员会的主席组成了中期技术网络执行委员会，这是中期技术网络活动的主要决策机构。 MTN成立于2006年，由NIH提供资金，负责从产品开发的早期阶段到监管当局的最终批准，开发安全有效的杀微生物剂。本赠款申请详细说明了MTN对艾滋病毒预防的贡献，确定了下一个供资周期--从2013年12月1日至2010年11月30日的7年期--的网络领导和业务结构，并描述了6个具体的挑战和需要改进的领域。该申请提出了MTN的15个具体目标，这些目标建立在其6年来开发和/或完成33项临床方案的经验、相关经验教训、遇到的障碍、确定的差距以及环境变化和压力的基础上。

DESCRIPTION: Component 1 (Overview): The MTN Leadership Group comprises a Leadership Operations Center (LOC), Laboratory Center (LC), and Statistical and Data Management Center (SDMC), for each of which thematically linked but separate applications have been submitted. The LOC is led by two Principal Investigators: Drs. Sharon Hillier and Ian McGowan, both located at the Magee Womens Research Institute in Pittsburgh, each providing distinct but complementary expertise. Dr. Hillier provides primary leadership for MTN's vaginal microbicide development and female reproductive health; Dr. McGowan leads the MTN rectal microbicide research agenda and mucosal immunology program. The LOC also comprises the PIs for the Operations Support Core (Cates), University of Washington Core (Celum), the LC (Dezzutti), and the SDMC (Brown), which work together and with the network-affiliated Clinical Trial Units/Sites to implement the research agenda. The LOC is supported by 3 Working Groups--Biomedical Science, Behavioral Research, and Community--and 3 Network Committees: Study Monitoring, Network Evaluation, and Manuscript Development. The PIs and the Chairs of the Working Groups and Network Committees constitute the MTN Executive Committee, the primary decision-making body for MTN activity. Established in 2006 with NIH funding, the MTN was charged with developing safe and effective microbicides from the early stages of product development through final approval by regulatory authorities. The present grant application details MTN contributions to HIV prevention, defines network leadership and operational structures for the next funding cycle--a 7-year period from 12/1/13 through 11/30/20-and describes 6 specific areas of challenge and needed improvement. The application presents 15 Specific Aims for MTN that build on its 6 years of experience with developing and/or completing 33 clinical protocols, associated lessons learned, obstacles encountered, gaps identified; and environmental changes and pressures.