UZ-UCSF Clinical Trials Unit

UZ-UCSF 临床试验单位

• 批准号: 7364628
• 负责人: ZVAVAHERA MIKE CHIRENJE
• 金额: $ 825.01万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7364628
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Adolescent; Adult; Affect; Area; Arts; Award; California; Childhood; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials-Pediatric AIDS; Communication; Communities; Counseling; Development; Ensure; Ethics; Funding; Future; Goals; HIV prevention trials network; Institution; International; Intervention Trial; Laboratories; Leadership; Microbicide Trials Network; Pharmacy facility; Productivity; Protocols documentation; Public Health; Research; Research Activity; Research Infrastructure; Research Personnel; Research Priority; Research Support; San Francisco; Southern Africa; Structure; System; Training; Universities; Work; Zimbabwe; clinical research site; data management; experience; human subject; implementation research; outreach; programs; quality assurance

DESCRIPTION (provided by applicant): The goal of the University of Zimbabwe-University of California San Francisco Clinical Trials Unit (UZ-UCSF CTU) is to provide scientific leadership, a well organized and efficient research-support infrastructure, and even high-capacity Clinical Research Sites (CRS) to conduct state-of-the-art HIV/AIDS prevention and treatment intervention trials in Zimbabwe, with potential application throughout southern Africa and other highly affected regions. Currently there are three research programs in Zimbabwe that participate in DAIDS network activities: 1) UZ-UCSF HIV Prevention Trials Unit (HPTN funding); 2) the UZ-Clinical Research Centre (ACTG and HPTN funding); and 3) the UZ Pediatric AIDS Clinical Trials Unit (PACTG funding), each with well-established CRS. We propose to integrate the three programs and seven of their CRS to continue implementation of 12 transitional protocols (HPTN 035, 046, 052; ACTG A5175, A5199, A5221, A5208, A5225; and PACTG A5190/P1054), and to conduct future trials affiliated with four DAIDS networks; the Adult Clinical Trials Group (ACTG), HIV Prevention Trials Network (HPTN), the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT), and Microbicides Trial Network (MTN). Our CTU brings together many of the world's leading researchers from the finest research and public health institutions around the world. The specific aims in this proposal are to: Aim 1. Develop an integrative Clinical Trials Unit by consolidating three existing research programs into a centralized infrastructure to implement existing transitional protocols associated with four DAIDS Clinical Trials Leadership Groups, and to expand our scientific and logistical capacity to participate in future trials. Objective 1 .a. Provide scientific leadership that promotes high quality research, contributes to priority research areas, oversees capable and productive CRS and supports the development of new researchers. Objective 1 .b. Develop centralized research support components to coordinate fiscal management, quality assurance and control, regulatory, human subjects and ethics, data management, laboratory, pharmacy, training, community advisory board liaison, and counseling functions for all UZ-UCSF CTU activities. Objective 1 .c. Strengthen our management and communication systems to ensure high quality research implementation and effective oversight of the seven proposed CRS. Objective 1 .d. Manage transition of clinical protocols from current awards to the proposed CTU structure. Aim 2. Contribute scientifically to the leadership and prioritization of research activities in four networks: ACTG, HPTN, IMPAACT, and MTN. Aim 3. Achieve meaningful community partnership in the CTU clinical research activities through effective outreach and communication and Community Advisory Board (CAB) participation. Aim 4. Work with established clinical research sites that have proven capacity, experience and a record of scientific productivity. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：津巴布韦大学-加州大学旧金山分校临床试验中心 (UZ-UCSF CTU) 的目标是提供科学领导力、组织良好且高效的研究支持基础设施，甚至高能力临床研究中心 (CRS) 将在津巴布韦开展最先进的艾滋病毒/艾滋病预防和治疗干预试验，并有可能在整个南部非洲和其他受影响严重的地区得到应用。目前津巴布韦有三个研究项目参与 DAIDS 网络活动： 1) UZ-UCSF HIV 预防试验单位（HPTN 资助）； 2) UZ临床研究中心（ACTG和HPTN资助）； 3) UZ 儿科艾滋病临床试验单位（PACTG 资助），每个单位都有完善的 CRS。我们建议整合这三个计划及其七个 CRS，以继续实施 12 个过渡协议（HPTN 035、046、052；ACTG A5175、A5199、A5221、A5208、A5225；和 PACTG A5190/P1054），并进行未来的试验隶属于四个 DAIDS 网络；成人临床试验组 (ACTG)、艾滋病毒预防试验网络 (HPTN)、国际孕产妇儿科青少年艾滋病临床试验 (IMPAACT) 和杀菌剂试验网络 (MTN)。我们的 CTU 汇集了来自世界各地最优秀的研究和公共卫生机构的许多世界领先的研究人员。该提案的具体目标是： 目标 1. 通过将三个现有研究计划整合为一个集中基础设施，建立一个综合性临床试验单位，以实施与四个 DAIDS 临床试验领导小组相关的现有过渡方案，并扩大我们的科学和后勤能力参加未来的试验。目标 1.a.提供科学领导力，促进高质量研究，为优先研究领域做出贡献，监督有能力和富有成效的 CRS 并支持新研究人员的发展。目标 1.b.开发集中研究支持组件，以协调所有 UZ-UCSF CTU 活动的财务管理、质量保证和控制、监管、人类受试者和道德、数据管理、实验室、药房、培训、社区咨询委员会联络和咨询职能。目标 1.c.加强我们的管理和沟通系统，以确保高质量的研究实施和对七项拟议的 CRS 的有效监督。 目标 1.d. 管理临床方案从当前奖项到拟议的 CTU 结构的过渡。 目标 2. 为四个网络中的研究活动的领导和优先排序做出科学贡献：ACTG、HPTN、IMPAACT 和 MTN。目标 3. 通过有效的外展和沟通以及社区咨询委员会 (CAB) 的参与，在 CTU 临床研究活动中实现有意义的社区伙伴关系。目标 4. 与具有经过验证的能力、经验和科学生产力记录的既定临床研究机构合作。 行政部分：