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

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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.