University of North Carolina AIDS Clinical Trials Unit (UNC ACTU)

北卡罗来纳大学艾滋病临床试验中心 (UNC ACTU)

• 批准号: 8076503
• 负责人: Joseph J Eron
• 金额: $ 17.48万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-07-01 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8076503
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Adult; Affect; Area; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Unit; Comorbidity; Country; County; Data Quality; Enrollment; Funding; HIV; HIV Infections; HIV Vaccine Trials Network; HIV prevention trials network; HIV vaccine; Health; Health Sciences; Hospitals; Human; Leadership; North Carolina; Population; Prevention; Prevention strategy; Protocols documentation; Recruitment Activity; Research; Research Personnel; Research Priority; Resources; Retinal Cone; Services; Site; Structure; Training; Translational Research; Underserved Population; Universities; clinical research site; data management; drug development; experience; flexibility; forest; improved; outreach; vaccine development

DESCRIPTION (provided by applicant): This application proposes to establish the UNC-Chapel Hill Clinical Trials Unit (UNC-CH CTU) and its attendant clinical sites at UNC Chapel Hill, UNC Wake County Health and Human Services, Moses Cone Hospital, and Wake Forest University Health Sciences. This pluripotential unit and sites propose to efficiently recruit, enroll and retain subjects on protocols affiliated with three NIH-funded multi-center clinical research groups; Adult Aids Clinical Trials Group (ACTG), HIV Prevention Trials Network (HPTN), and HIV Vaccine Trials Network (HVTN) that will address four NIH/DAIDS clinical research priority areas: 1) Translational Research and Drug Development (ACTG), 2) Optimization of Clinical Management, including Co-morbidities (ACTG), 3) Prevention of HIV Infection (HPTN), and 4) HIV Vaccines (HVTN). The UNC-CH CTU and the four clinical research sites have extensive experience in HIV-related clinical trials including participation in the ACTS for 18 years as one of the premier units in that organization. The leadership of the Unit and Sites has the appropriate expertise to conduct these trials and to maximize the scientific opportunities by integrating this robust expertise in the 4 high priority research areas. The structure of the UNC-CH CTU and sites allows for flexible and responsive clinical research that will build and strengthen research capacity focusing on underserved populations in the Southeastern US, serving the population most affected by HIV in our country. Our Structure maximizes efficiency by sharing key resources amongst priority areas including investigators, sites and unit staff, training, protocol implementation, management, regulatory services, outreach, recruitment, and data management and data quality. The UNC CTU and its four Clinical Research Sites will improve the treatment of HIV and decrease HIV spread by contributing to HIV prevention strategies and HIV vaccine development. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：本申请提议建立UNC教堂山临床试验单元（UNC-CH CTU）及其服务员在UNC Chapel Hill，UNC Wake County Health and Humen Services，Moses Cone Hospital，Moses Cone Hospital和Wake的临床站点森林大学健康科学。这个多功能单元和站点建议有效地招募，招募和保留受试者，该协议与三个NIH资助的多中心临床研究小组相关的方案；成人艾滋病临床试验组（ACTG），HIV预防试验网络（HPTN）和HIV疫苗试验网络（HVTN），该网络（HVTN）将解决四个NIH/DAIDS临床研究优先领域：1）转化研究和药物开发（ACTG），2），2）临床管理的优化，包括合并症（ACTG），3）预防HIV感染（HPTN）和4）HIV疫苗（HVTN）。 UNC-CH CTU和四个临床研究网站在与HIV相关的临床试验中具有丰富的经验，包括作为该组织中的主要单位之一参加了18年的行为。该部门和网站的领导能力具有适当的专业知识，可以通过将这种强大的专业知识整合到4个高优先研究领域，从而最大程度地进行这些试验并最大程度地利用科学机会。 UNC-CH CTU和站点的结构允许灵活而响应的临床研究，该研究将建立和增强美国东南部服务不足人群的研究能力，为我们国家受HIV影响最大的人群提供服务。我们的结构通过在优先领域（包括调查人员，站点和单位员工），培训，协议实施，管理，监管服务，外展，招聘以及数据管理以及数据管理和数据质量在内的优先领域之间共享关键资源，从而最大程度地提高效率。 UNC CTU及其四个临床研究地点将通过促进HIV预防策略和HIV疫苗的发展来改善HIV的治疗，并减少HIV传播。 管理组件：