Statistical and Data Management Center for the AIDS Clinical Trials Group

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DESCRIPTION (provided by applicant): This application is a proposal to serve as the Statistical and Data Management Center (SDMC) of the AIDS Clinical Trials Group (ACTG), in affiliation with the ACTG Leadership Group headed by Dr. Constance A. Benson (UCSD). The ACTG is proposing a therapeutic research agenda to address objectives in the NIAID high priority research areas of Translational Research/Drug Development; Optimization of Clinical Management; Vaccine Research and Development; Prevention of Mother-to-Child Transmission of HIV Infection; and Prevention of HIV. In addition, the ACTG is applying for funding to carry out research in the NIDCR priority area. Our Specific Aims are to support the research agenda of the ACTG by providing a group of highly experienced statisticians, data managers and other professionals who are knowledgeable in all aspects of HIV therapeutic research and an organizational structure that promotes this work with the ACTG; to provide expertise and high quality clinical and laboratory data management and communications systems to support the development, conduct and analysis of ACTG studies; and to advance the mission of the ACTG through innovation in study design and analysis, providing leadership in cross-study analyses and collaborating effectively with other HIV Trials Networks and HIV research organizations. The expertise provided by the SDMC will help advance HIV therapeutic research by ensuring that ACTG clinical trials and other studies are efficiently designed and analyzed to the highest standards. This research will continue to make significant contributions in advancing optimal treatment of HIV-infected individuals both in the Unites States and internationally. Translational Research/Drug Development