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: 7649348
• 负责人: Michael David Hughes
• 金额: $ 1393.59万
• 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/7649348
• 关键词: AIDS clinical trial group; Address; Adverse effects; Area; Clinical; Clinical Data; Clinical Management; Clinical Trials; Collaborations; Commit; Communication; Computers; Data; Data Collection; Databases; Development; Development Plans; Electronics; Ensure; Epidemiology; Funding; HIV; HIV Infections; Head; Individual; Infection; Infection prevention; International; Laboratories; Leadership; Life; Methods; Mission; Monitor; National Institute of Allergy and Infectious Disease; National Institute of Dental and Craniofacial Research; Office of Administrative Management; Operative Surgical Procedures; Pathogenesis; Play; Policies; Prevention; Procedures; Protocols documentation; Randomized; Research; Research Design; Research Personnel; Research Priority; Research Support; Resource Allocation; Resources; Role; Shipping; Ships; Site; Specimen; Support System; System; Technology; Therapeutic Human Experimentation; Therapeutic Intervention; Training; Translational Research; United States; Vaccine Research; Vertical Disease Transmission; Work; base; data acquisition; data management; design; drug development; experience; flexibility; high standard; 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)：此申请是一项建议，拟作为艾滋病临床试验小组(ACTG)的统计和数据管理中心(SDMC)，隶属于由康斯坦斯·A·本森博士(UCSD)领导的ACTG领导小组。ACTG正在提出一项治疗研究议程，以解决NIAID高度优先的研究领域的目标，这些领域包括转化研究/药物开发；优化临床管理；疫苗研发；预防艾滋病毒母婴传播；以及预防艾滋病毒。此外，ACTG正在申请资金，以开展NIDCR优先领域的研究。我们的具体目标是支持ACTG的研究议程，提供一批经验丰富的统计学家、数据经理和其他专业人员，他们在艾滋病毒治疗研究的各个方面都有知识，并建立一个促进ACTG这项工作的组织结构；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、进行和分析；并通过研究设计和分析方面的创新，推动ACTG的使命，在跨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有效合作。SDMC提供的专业知识将确保ACTG临床试验和其他研究以最高标准进行有效设计和分析，从而有助于推动艾滋病毒治疗研究。这项研究将继续为推动美国和国际上艾滋病毒感染者的最佳治疗作出重大贡献。 转化研究/药物开发