HIV/AIDS Clinical Trials Unit

艾滋病毒/艾滋病临床试验单位

• 批准号: 8131282
• 负责人: John A Bartlett
• 金额: $ 85.92万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8131282
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Academic Medical Centers; Accountability; Address; Adult; Area; Child; Clinical Management; Clinical Research; Clinical Trials Unit; Communication; Communities; Creativeness; Ensure; Environment; Foundations; Funding; Leadership; Life; Medical center; Mothers; Persons; Prevention; Procedures; Recording of previous events; Research; Research Personnel; Role; Southeastern United States; Structure; Tanzania; Translational Research; Work; clinical research site; high standard; operation; pediatric AIDS

Composite The Duke University Medical Center (DUMC) Clinical Trials Unit (CTU) proposes to address the key scientific areas of translational research and optimization of clinical management in children and adults, and prevention of mother to child transmission.The CTU and its affiliated Clinical Research Sites (CRS's) bring scientific leadership, a rich history of successful collaborative clinical research within networks, a strong and efficient organizational foundation for the conduct of rigorous clinical research, and access to growing numbers of underserved persons living with HIV/AIDS (PLWHA) in the US Southeast and Tanzania. The scientific leadership of the CTU and CRS investigators is reflected in their past participation in the Adult and Pediatric AIDS Clinical Trials Groups (ACTG's), and the expanding portfolio of NIH-funded research at DUMC and the Kilimanjaro Christian Medical Centre (KCMC). The three CRS's included in the CTU proposal each bring unique value and are highly motivated to perform the proposed work, and together they will constitute a formidable research enterprise. Their interactions will be guided by an administrative structure which supports a dynamic intellectual environment to enhance scientific creativity, clear roles and responsibilities for investigators and staff, facile and regular communications, harmonized standard operating procedures across CRS's which emphasize CTU accountability through quality management, and a strong commitment to serve the community of PLWHA. The clarity of CTU and CRS organization and operations will ensure that it operates efficiently to perform clinical research at the highest standard, with the ability to rapidly respond to evolving opportunities.

合成的 杜克大学医学中心 (DUMC) 临床试验部门 (CTU) 建议解决关键问题 转化研究的科学领域和儿童临床管理的优化 成人和预防母婴传播。CTU 及其附属临床研究 站点（CRS）带来科学领导力和成功合作临床研究的丰富历史 在网络内，为进行严格的临床提供强大而有效的组织基础 研究以及接触到越来越多服务不足的艾滋病毒/艾滋病感染者 (PLWHA) 美国东南部和坦桑尼亚。 CTU 和 CRS 研究人员的科学领导力 反映在他们过去参与成人和儿童艾滋病临床试验组 (ACTG) 中，以及 DUMC 和乞力马扎罗基督教医疗中心的 NIH 资助研究不断扩大 （KCMC）。 CTU 提案中包含的三个 CRS 均具有独特的价值，并且具有很高的价值。 积极开展拟议的工作，它们共同将构成一项艰巨的研究 企业。他们的互动将受到支持动态的管理结构的指导 增强科学创造力的智力环境，明确的角色和责任 调查人员和工作人员、方便和定期的沟通、统一的标准操作 跨 CRS 的程序，通过质量管理强调 CTU 责任，以及 坚定致力于为感染者社区服务。 CTU 和 CRS 组织的清晰度 运营将确保其高效运作，以最高标准进行临床研究， 具有快速响应不断变化的机会的能力。