Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)

统计和数据管理中心（SDMC）、艾滋病临床试验组（ACTG）

• 批准号: 10316777
• 负责人: Marlene Ann Cooper
• 金额: $ 240.52万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-07 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10316777
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adult; Area; Arts; Biometry; Boston; California; Clinical; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Network; Collaborations; Communication; Communities; Data; Data Collection; Data Management Resources; Databases; Development; Diagnosis; Disease remission; Ensure; Epidemiologist; Epidemiology; Foundations; Funding; Future; HIV; HIV Infections; Hepatitis B Virus; Industry Standard; Infection; Information Dissemination; Infrastructure; International; Intervention; Laboratories; Lead; Leadership; Life; Management Information Systems; Methodology; 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; San Francisco; Science; Site; Specimen; Statistical Data Interpretation; System; Technology; Therapeutic Clinical Trial; Training; Tuberculosis; United States; Universities; Viral hepatitis; Work; co-infection; comorbidity; data harmonization; data management; data sharing; design; epidemiologic data; experience; flexibility; frontier; high standard; improved; innovation; interest; novel; optimal treatments; organizational structure; research and development; trial design; tuberculosis treatment

Project Summary/Abstract This application requests renewal of funding to serve as the Statistical and Data Management Center of the AIDS Clinical Trials Group (ACTG). The ACTG is an international clinical trials network which is proposing to address objectives in NIAID high priority research areas for adults 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 ART (“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 co-morbidities and co-infections, including curative strategies hepatitis B virus co-infection. The application's specific aims and long-term objectives are: to support the international research agenda of the ACTG 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 ACTG 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 the ACTG through innovation in study design and analysis and the development of efficient methods and systems, that facilitate the work of the ACTG 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, and includes a subcontract to University of California San Francisco to support additional tuberculosis trial design expertise. 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 艾滋病临床试验组 (ACTG) 中心。 ACTG是一项国际临床试验 该网络提议实现 NIAID 成人高优先研究领域的目标 感染艾滋病毒。具体来说：评估针对艾滋病毒感染的新颖且持久的干预措施； 确定在缺乏抗逆转录病毒治疗的情况下减少艾滋病毒储存和控制艾滋病毒复制的策略 （“无 ART 缓解”）；改善结核病的诊断和治疗，特别是在 合并感染艾滋病毒的人；并改善合并症的预防和治疗 合并感染，包括乙型肝炎病毒合并感染的治疗策略。 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 ACTG 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、开展和 具有专家统计和数据管理领导力以及高水平的 ACTG 研究分析 符合标准的高质量临床和实验室数据管理和通信系统 符合监管要求，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 ACTG 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 ACTG 的工作并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 T.H. 中心陈公共卫生学院将提供生物统计领导， 并包括与加州大学旧金山分校的分包合同，以支持额外的 结核病试验设计专业知识。第二个是前沿数据管理中心 科学技术研究基金会将提供数据方面的专业知识和领导力 管理系统，并对数据收集、质量和完整性负主要责任。