Statistical and Data Management Center for the AIDS Clinical Trials Group

描述（由申请人提供）：本申请是一份作为艾滋病临床试验组（ACTG）统计和数据管理中心（SDMC）的提案，隶属于ACTG领导小组，由Dr. Constance a . Benson （UCSD）领导。ACTG正在提出一项治疗研究议程，以解决NIAID转化研究/药物开发高优先研究领域的目标；优化临床管理；疫苗研究与开发；预防艾滋病毒母婴传播；预防艾滋病毒。此外，ACTG正在申请资助，以开展NIDCR优先领域的研究。我们的具体目标是通过提供一组经验丰富的统计学家、数据管理人员和其他专业人员来支持ACTG的研究议程，他们对艾滋病毒治疗研究的各个方面都很了解，并建立一个组织结构来促进ACTG的这项工作；提供专业知识和高质量的临床和实验室数据管理和通信系统，以支持ACTG研究的发展、进行和分析；通过创新研究设计和分析，在交叉研究分析方面发挥领导作用，并与其他艾滋病毒试验网络和艾滋病毒研究组织进行有效合作，推进ACTG的使命。SDMC提供的专业知识将有助于推进艾滋病毒治疗研究，确保ACTG临床试验和其他研究按照最高标准进行有效设计和分析。这项研究将继续在推进美国和国际上艾滋病毒感染者的最佳治疗方面作出重大贡献。

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