SDMC - IMPAACT Leadership Group

SDMC - IMPAACT 领导小组

• 批准号: 10307074
• 负责人: Marlene Ann Cooper
• 金额: $ 1171.97万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-29 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10307074
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adolescent; Area; Biometry; Boston; Breast Feeding; Child; Childhood; Clinical; Clinical Trials; Clinical Trials Network; Collaborations; Communities; Data; Data Collection; Data Management Resources; Databases; Development; Diagnosis; Disease remission; Ensure; Epidemiologist; Epidemiology; Foundations; Funding; Future; HIV; HIV Infections; Industry Standard; Infant; Information Dissemination; Infrastructure; International; International Aspects; International Maternal Pediatric Adolescent AIDS Clinical Trials; Intervention; Laboratories; Lead; Leadership; Life; Management Information Systems; Methods; Mission; Monitor; National Institute of Allergy and Infectious Disease; Prevention; Procedures; Public Health Schools; Reporting; Request for Applications; Research; Research Design; Research Personnel; Research Priority; Role; Science; Site; Specimen; Statistical Data Interpretation; System; Technology; Therapeutic Clinical Trial; Training; Tuberculosis; United States; Woman; Work; antiretroviral therapy; co-infection; data communication; data harmonization; data management; data sharing; design; epidemiologic data; experience; flexibility; frontier; high standard; improved; innovation; interest; international center; novel; optimal treatments; organizational structure; pregnant; research and development; tuberculosis treatment

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.

项目概要/摘要 该申请要求更新资金以充当统计和数据管理 国际孕产妇儿科青少年艾滋病临床试验网络中心 (IMPAACT) 是一个国际临床试验网络，旨在解决这一问题。 NIAID 婴儿、儿童、青少年和孕妇优先研究领域的目标 具体来说：评估新颖性和耐用性。 针对艾滋病毒感染的干预措施；确定减少艾滋病毒储存和控制的策略 在没有抗逆转录病毒治疗的情况下艾滋病毒复制（“无抗逆转录病毒治疗缓解”）； 结核病的诊断和治疗，特别是合并感染艾滋病毒的结核病； 预防和治疗艾滋病毒并发症和合并感染。 该应用程序的具体目标和长期目标是： 支持国际 通过提供一组经验丰富的统计学家来制定 IMPAACT 的研究议程， 流行病学家、数据管理员和其他对相关研究有浓厚兴趣的专业人士 HIV 感染及其并发症和合并感染；支持发展、实施和 在专家统计和数据管理领导力以及高度的影响下对 IMPAACT 研究进行分析 符合标准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，满足行业标准并完全融入质量 管理系统工作流程；并通过创新推进 IMPAACT 的使命 研究设计和分析以及有效方法和系统的开发，以促进 IMPAACT 的工作并通过协作促进协调和数据共享 组织。 拟议的 SDMC 由两个部分组成：一是统计和数据分析。 哈佛大学陈曾熙公共卫生学院中心将提供生物统计领导。 第二个是前沿科技研究数据管理中心 基金会将提供数据管理系统方面的专业知识和领导力，并拥有 对数据收集、质量和完整性负主要责任。