SDMC - IMPAACT Leadership Group

项目摘要/摘要 这项申请要求更新资金，以作为统计和数据管理 国际母儿青少年艾滋病临床试验网络中心 (IMPAACT)。IMPAACT是一个国际临床试验网络，正在提议解决 目标在NIAID的婴幼儿、儿童、青少年和孕妇优先研究领域 以及哺乳感染艾滋病毒的妇女。具体地说：评价新奇耐用 针对艾滋病毒感染的干预措施；确定减少艾滋病毒宿主和控制的战略 在没有抗逆转录病毒治疗的情况下复制艾滋病毒(“不含抗逆转录病毒药物的缓解”)； 诊断和治疗结核病，特别是在那些同时感染艾滋病毒的人中；并改善 预防和治疗艾滋病毒并发症和合并感染。 应用程序的具体目标和长期目标是：支持国际 IMPAACT的研究议程通过提供一批经验丰富的统计学家， 流行病学家、数据经理和其他对研究有浓厚兴趣的专业人士 艾滋病毒感染及其并发症和混合感染；支持发展、开展和 分析IMPAACT研究，具有专家统计和数据管理领导和高级 符合以下要求的高质量临床和实验室数据管理和通信系统 符合法规要求，符合行业标准，并完全融入质量 管理系统工作流程；并通过在以下方面的创新推进IMPAACT的使命 研究设计和分析以及开发有效的方法和系统，以促进 通过协作促进协调和数据共享 组织。 拟议的SDMC由两个组成部分组成。一是统计和数据分析 该中心将提供生物统计学方面的领导。 第二个是前沿科技研究中心的数据管理中心 基金会，将提供数据管理系统方面的专业知识和领导能力，并拥有 主要负责数据收集、质量和完整性。

Project Summary/Abstract This application requests renewal of funding to serve as the Statistical and Data Management Center of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT). IMPAACT is an international clinical trials network which is proposing to address objectives in NIAID high priority research areas for infants, children, adolescents, and pregnant and breastfeeding women living with HIV. Specifically: to evaluate novel and durable interventions targeting HIV infection; to identify strategies to reduce HIV reservoirs and control HIV replication in the absence of antiretroviral treatment (“ART-free remission”); to improve the diagnosis and treatment of tuberculosis, especially in those co-infected with HIV; and to improve the prevention and treatment of complications and co-infections of HIV. The application's specific aims and long-term objectives are: to support the international research agenda of IMPAACT by providing a group of highly-experienced statisticians, epidemiologists, data managers and other professionals who have a deep interest in research in HIV infection and its complications and co-infections; to support the development, conduct and analysis of IMPAACT studies with expert statistical and data management leadership and high quality clinical and laboratory data management and communications systems which comply with regulatory requirements, meet industry standards and are fully integrated into quality management system workflows; and to advance the mission of IMPAACT through innovation in study design and analysis and the development of efficient methods and systems, that facilitate the work of IMPAACT and promote harmonization and data sharing with collaborating organizations. The proposed SDMC consists of two components. One is a Statistical and Data Analysis Center at Harvard T.H. Chan School of Public Health which will provide biostatistical leadership. The second is a Data Management Center at Frontier Science & Technology Research Foundation which will provide expertise and leadership in data management systems and has primary responsibility for data collection, quality and integrity.