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 病例临床试验股(CTU)由三个高产的临床研究站点组成：病例/UHC在 克利夫兰、辛辛那提大学和坎帕拉联合临床研究中心。这其中的每一个 Three Sites是一家表现最好的ACTG治疗试验站点，具有出色的收益，出色的业绩 评估和在领导网络中的主要作用，它是科学生产力。的一个关键主题 这个CTU是我们的临床研究组合与我们的基础和转译研究的紧密联系 程序。因此，CASE CTU的三个CRS站点将全面的研究计划带给 进取号。由在各自领域处于国内和国际领先地位的教员领导，这些单位已做好准备。 为执行委员会所针对的每个优先领域作出实质性贡献：炎症/完 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。这个 CASE/UHC CRS也是HVTN的一个富有成效的成员。案例/UHC CRS一直是最高的- 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的参与者 在这一供资周期内，将在人群中进行多项HVTN试验。在某些情况下，注册人数 大大超出了网站的预期。此外，案件CTU调查人员高度重视 在免疫反应形式监测方面有丰富经验的资深研究人员 在评估各种免疫战略以提高疫苗响应性方面，以及在 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、管理良好的CRS，一直在为 ACTG成立于1987年，是美国注册人数排名第一的网站。除了他们的 在注册方面表现非凡，该网站在代谢方面拥有广泛积累的专业知识 此外，它还是一个高性能的特定于方案的HPTN站点。JCRC就是其中之一 是ACTG中表现最好的国际网站之一，是以下贡献的关键组成部分 CTU的案子被列入了结核病议程。它也是#年第一个丙型肝炎治疗临床试验的地点。 非洲，ACTG A5360协议。JCRC CRS以前也展示了它有能力访问 在明确界定的高危人群中有大量受试者，曾是 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 如果被选为站点，也是如此。因此，组成该CTU的三个CRS被定位为提供持续的 对NIAID网络治疗和预防议程的领导和贡献。