Case Clinical Trials Unit

病例临床试验单位

• 批准号: 10532725
• 负责人: JEFFREY M. JACOBSON
• 金额: $ 243.64万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-13 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10532725
• 关键词: AIDS clinical trial group; AIDS prevention; Address; Adult; Africa; African; Anti-Retroviral Agents; Area; Basic Science; Biopsy; Cerebrospinal Fluid; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Unit; Collaborations; Complement; Databases; Development; Disease; Doctor of Philosophy; Enrollment; Epidemic; Evaluation; Faculty; Funding; Grant; HIV; HIV Antibodies; HIV Infections; HIV Vaccine Trials Network; HIV prevention trial; HIV vaccine; HIV/TB; Health; Hepatitis; Hepatitis C Therapy; Immune response; Immunization; Immunocompetence; Immunologic Monitoring; Immunology; Immunotherapy; Inflammation; Infrastructure; International; Joints; Laboratories; Leadership; Leukapheresis; Life; Link; Logistics; Metabolic; Monitor; Monitoring Clinical Trials; National Institute of Allergy and Infectious Disease; Organ; PET/CT scan; Pathogenesis; Performance; Persons; Pharmaceutical Preparations; Phase; Population; Positioning Attribute; Predisposition; Prevention; Prevention Research; Productivity; Protocols documentation; Research; Research Personnel; Risk; Role; Site; Special Population; Tissue Sample; Translational Research; Tuberculosis; Uganda; United States National Institutes of Health; Universities; antiretroviral therapy; clinical center; clinical infrastructure; clinical research site; clinical trial analysis; determinants of treatment resistance; expectation; experience; high risk; improved; interest; lymph nodes; member; notch protein; novel; outreach program; participant enrollment; prevent; recruit; targeted treatment; translational research program; treatment trial; vaccination strategy; vaccine response; vaccine trial; volunteer

ABSTRACT The Case Clinical Trials Unit (CTU) comprises three highly productive clinical research sites: Case/UHC in Cleveland, the University of Cincinnati, and the Joint Clinical Research Center in Kampala. Each of these three sites is a top performing ACTG treatment trial site with excellent accruals, outstanding performance evaluations and major roles in the leadership of the network and it is scientific productivity. A key theme of this CTU is the close link of our clinical research portfolio with our basic and translational research programs. Thus, the three CRS sites of the Case CTU bring a comprehensive research plan to the enterprise. Led by faculty who are national and international leaders in their fields, these units are poised to make substantive contributions to each of the priority areas targeted by the ACTG: Inflammation/End Organ Disease, Antiretroviral Medications, HIV Eradication and Cure, Tuberculosis, and Hepatitis. The Case/UHC CRS has also been a productive member of the HVTN. The Case/UHC CRS has been a high- performing site in this network, having enrolled participants, including some from difficult-to-reach segments of the population, into multiple HVTN trials during this funding cycle. In some cases, enrollment has substantially exceeded expectations from the site. Additionally, Case CTU investigators are highly accomplished researchers who have extensive experience in the monitoring of immune responses form immunization, in evaluating diverse immunization strategies to enhance vaccine responsiveness, and in the use of vaccine responsiveness as a readout of immune competence. The University of Cincinnati CRS is a highly efficient, well-managed CRS that has been conducting clinical and translational research for the ACTG since 1987, and is the number 1 site by number of participants enrolled in the US. In addition to their extraordinary performance on enrollments, the site has extensive accumulated expertise in the metabolic complications of HIV, and is additionally a high-performing protocol-specific HPTN site. The JCRC is one of the top-performing international sites in the ACTG, and is the critical component in the contributions of the Case CTU to the tuberculosis agenda. It is also the site of the first hepatitis C treatment clinical trial in Africa, the ACTG A5360 protocol. The JCRC CRS has also previously demonstrated its ability to access large numbers of subjects in well-defined populations at high risk for HIV infection, having been the site of the first HIV vaccine trial in Africa, and can begin contributing to the HIV prevention networks immediately as well if selected as a site. Thus, the three CRS that comprise this CTU are positioned to provide sustained leadership and contribution to the treatment and prevention agenda of the NIAID Networks.

摘要 病例临床试验单位（CTU）由三个高产的临床研究中心组成： 克利夫兰、辛辛那提大学和坎帕拉的联合临床研究中心。这一切成功都 三个研究中心是一个表现最好的ACTG治疗试验中心，具有出色的应计利润， 评价和网络的领导作用，它是科学生产力的主要作用。的一个关键主题 该CTU是我们临床研究组合与我们基础和转化研究的紧密联系 程序.因此，Case CTU的三个CRS站点为全球带来了全面的研究计划 企业.在各自领域的国家和国际领导者的带领下，这些单位已经准备好了 为ACTG针对的每个优先领域做出实质性贡献：炎症/结束 器官疾病，抗逆转录病毒药物，艾滋病毒根除和治疗，结核病和肝炎。的 Case/UHC CRS也是HVTN的一个富有成效的成员。案例/UHC CRS一直很高- 在这个网络中的执行站点，已经招募了参与者，包括一些来自难以到达的部分 在本资助周期内，将人群纳入多项HVTN试验。在某些情况下， 大大超出了网站的预期。另外，反恐组的调查人员 在监测免疫反应方面有丰富经验的有成就的研究人员， 免疫接种，评价各种免疫战略，以提高疫苗的反应， 使用疫苗反应性作为免疫能力的读数。辛辛那提大学CRS 是一个高效，管理良好的CRS，一直在进行临床和转化研究， ACTG自1987年以来，是美国招募参与者人数最多的研究中心。除了它们 在注册方面的卓越表现，该网站在代谢方面积累了广泛的专业知识， 它是一个高性能的方案特异性HPTN网站。JCRC是一个 ACTG中表现最好的国际网站之一，是贡献的关键组成部分， 把反恐小组的工作转移到结核病议程上它也是第一个丙型肝炎治疗临床试验的地点， 非洲，ACTG A5360协议。JCRC CRS此前也证明了其访问 明确定义的HIV感染高危人群中的大量受试者， 非洲第一个艾滋病毒疫苗试验，并可以立即开始为艾滋病毒预防网络做出贡献 如果被选为网站，也是如此。因此，包括该CTU的三个CRS被定位成提供持续的 领导和促进NIAID网络的治疗和预防议程。