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

描述（由申请人提供）：本申请提议建立北卡罗来纳大学教堂山临床试验单位（UNC- ch CTU）及其附属临床站点，北卡罗来纳大学教堂山分校，北卡罗来纳大学威克县卫生与人类服务部，摩西科恩医院和威克森林大学健康科学。这个多能单位和站点建议有效地招募、登记和保留与三个nih资助的多中心临床研究小组有关的方案的受试者；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），将解决NIH/DAIDS临床研究的四个优先领域：1)转化研究和药物开发（ACTG）， 2)临床管理优化，包括合并症（ACTG）， 3) HIV感染预防（HPTN）和4)HIV疫苗（HVTN）。UNC-CH CTU和四个临床研究点在艾滋病毒相关临床试验方面拥有丰富的经验，包括作为该组织的主要单位之一参加了18年的ACTS。单位和站点的领导具有适当的专业知识来进行这些试验，并通过将这些强大的专业知识整合到4个高优先研究领域来最大限度地利用科学机会。UNC-CH CTU的结构和地点允许灵活和反应迅速的临床研究，这将建立和加强研究能力，重点关注美国东南部服务不足的人群，为我国受艾滋病毒影响最严重的人群服务。我们的结构通过在优先领域共享关键资源来最大限度地提高效率，这些优先领域包括调查员，站点和单位人员，培训，协议实施，管理，监管服务，外展，招聘以及数据管理和数据质量。联合国军司令部CTU及其四个临床研究点将通过促进艾滋病毒预防战略和艾滋病毒疫苗的开发，改善艾滋病毒的治疗并减少艾滋病毒的传播。

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: