Case Clinical Trials Unit

病例临床试验单位

• 批准号: 10057995
• 负责人: JEFFREY M. JACOBSON
• 金额: $ 257.57万
• 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/10057995
• 关键词: AIDS clinical trial group; AIDS prevention; Address; Adult; Africa; African; Anti-Retroviral Agents; Area; Basic Science; Biopsy; Centers for Disease Control and Prevention (U.S.); Cerebrospinal Fluid; Clinical Research; Clinical Trials; 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; Participant; Pathogenesis; Performance; Persons; Pharmaceutical Preparations; Phase; Population; Positioning Attribute; Positron-Emission Tomography; Predisposition; Prevention; Prevention Research; Productivity; Protocols documentation; Research; Research Personnel; Resistance; Risk; Role; Site; Special Population; Tissue Sample; Translational Research; Tuberculosis; Uganda; United States National Institutes of Health; Universities; Vaccines; antiretroviral therapy; clinical center; clinical infrastructure; clinical research site; clinical trial analysis; 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; 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.

抽象的 案例临床试验单位 (CTU) 包括三个高效的临床研究中心： 案例/UHC 克利夫兰、辛辛那提大学和坎帕拉联合临床研究中心。这些中的每一个 三个站点是表现最佳的 ACTG 治疗试验站点，具有出色的应计收益和出色的表现 评估和网络领导力的主要作用是科学生产力。一个关键主题是 该 CTU 是我们的临床研究组合与基础研究和转化研究的紧密联系 程序。因此，Case CTU 的三个 CRS 站点为大家带来了全面的研究计划 企业。这些单位由各自领域的国内和国际领导者领导，准备就绪 为 ACTG 所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。这 Case/UHC CRS 也是 HVTN 的富有成效的成员。 Case/UHC CRS 一直是一个高 在此网络中执行站点，已注册参与者，包括一些来自难以到达的细分市场 在此资助周期内，将人口纳入多项 HVTN 试验。在某些情况下，注册 大大超出了现场的预期。此外，Case CTU 调查员高度重视 在监测免疫反应方面拥有丰富经验的研究人员 免疫，评估多种免疫策略以增强疫苗反应性，以及 使用疫苗反应性作为免疫能力的读数。辛辛那提大学 CRS 是一家高效、管理完善的 CRS，一直致力于以下领域的临床和转化研究： ACTG 自 1987 年以来一直是美国注册参与者数量排名第一的网站。除了他们的 在注册方面表现出色，该网站在代谢方面积累了丰富的专业知识 HIV 并发症，也是一个高性能的协议特定 HPTN 站点。 JCRC 是其中之一 ACTG 中表现最好的国际站点之一，并且是贡献的关键组成部分 将案例 CTU 纳入结核病议程。它也是中国第一个丙型肝炎治疗临床试验的地点 非洲，ACTG A5360 协议。 JCRC CRS 之前也展示了其访问的能力 明确人群中的大量受试者处于感染艾滋病毒的高风险， 非洲第一个艾滋病毒疫苗试验，可以立即开始为艾滋病毒预防网络做出贡献 如果选择作为站点也是如此。因此，组成该 CTU 的三个 CRS 旨在提供持续的 对 NIAID 网络的治疗和预防议程的领导和贡献。