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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）

基本信息

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
项目类别：
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

项目摘要

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.

项目总结/文摘