Statistical and Data Management Center for the AIDS Clinical Trials Group

艾滋病临床试验组统计和数据管理中心

• 批准号: 7489484
• 负责人: Michael David Hughes
• 金额: $ 1425.97万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-29 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7489484
• 关键词: AIDS clinical trial group; Acquired Immunodeficiency Syndrome; Address; Adverse effects; Area; Clinical; Clinical Data; Clinical Management; Clinical Trials, Other; Collaborations; Commit; Communication; Computers; Data; Data Collection; Databases; Development; Development Plans; Electronics; Ensure; Funding; HIV; HIV Infections; Head; Individual; Infection; Infection prevention; International; Laboratories; Leadership; Life; Methods; Mission; Monitor; National Institute of Allergy and Infectious Disease; Numbers; Office of Administrative Management; Operative Surgical Procedures; Pathogenesis; Play; Pliability; Policies; Prevention; Procedures; Protocols documentation; Randomized; Range; Research; Research Design; Research Personnel; Research Priority; Resource Allocation; Resources; Role; Shipping; Ships; Site; Specimen; Standards of Weights and Measures; Support System; Support of Research; System; Technology; Therapeutic Human Experimentation; Therapeutic Intervention; Training; Translational Research; United States; Vaccine Research; Vertical Disease Transmission; Work; base; concept; data acquisition; data management; design; drug development; experience; improved; innovation; member; organizational structure; programs; research and development; research study; software systems; transmission process

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

描述（由申请人提供）：本申请是作为艾滋病临床试验组（ACTG）统计和数据管理中心（SDMC）的提案，隶属于由 Constance A. Benson 博士领导的 ACTG 领导小组（加州大学圣地亚哥分校）。 ACTG 正在提出一项治疗研究议程，以实现 NIAID 转化研究/药物开发高度优先研究领域的目标；优化临床管理；疫苗研究与开发；预防艾滋病毒感染的母婴传播；和预防艾滋病毒。此外，ACTG 正在申请资金以在 NIDCR 优先领域开展研究。 我们的具体目标是通过提供一批经验丰富的统计学家、数据管理员和其他精通艾滋病毒治疗研究各个方面的专业人员以及与 ACTG 一起促进这项工作的组织结构来支持 ACTG 的研究议程；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 研究的开发、实施和分析；通过研究设计和分析方面的创新、在交叉研究分析中发挥领导作用以及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，从而帮助推进 HIV 治疗研究。这项研究将继续为美国和国际上推进艾滋病毒感染者的最佳治疗做出重大贡献。 转化研究/药物开发