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）：加利福尼亚州津巴布韦大学旧金山临床试验单元（UZ-UCSF CTU）的目标是提供科学领导力，有组织和有效的研究支持基础架构，甚至在整个范围内进行ZIM ART/AIDBENICE in the-ART PRINECTION，inty INDECTION INDECTION和TONESTION IADS PRINCETION，inter-ARTIONS PRINGETION INTECTIONS in the BEACTION the BEANTION the-abt PRICEINTIO南部非洲和其他受影响的地区。目前，津巴布韦有三个研究计划参加了daids网络活动：1）UZ-UCSF HIV预防试验单位（HPTN资金）； 2）UZ-Clinical Research Center（ACTG和HPTN资金）； 3）UZ小儿AIDS临床试验单元（PACTG资助），每个试验均具有良好的CR。我们建议将这三个程序和7个CRS整合起来，继续实施12个过渡协议（HPTN 035，046，052; ACTG A5175，A5199，A5199，A5221，A5208，A52225;和PACTG A5190/p1054），以及与未来的试验进行了四处相关的;成人临床试验组（ACTG），HIV预防试验网络（HPTN），国际母亲小儿青少年艾滋病临床试验（Incract）和Microbicides试验网络（MTN）。我们的CTU汇集了来自世界上最好的研究和全球公共卫生机构的许多世界主要研究人员。该提案中的具体目的是：目标1。通过将三个现有研究计划合并到集中式基础设施中，以实施与四个与四个DAIDS临床试验领导力小组相关的现有过渡方案，并扩大我们的科学和后勤能力以参与将来的试验，以实施现有的过渡方案，从而开发一个综合临床试验单元。目标1 .A。提供促进高质量研究的科学领导力，为优先研究领域做出贡献，监督有能力且富有成效的CRS，并支持新研究人员的发展。目标1 .b。开发集中的研究支持组件，以协调财政管理，质量保证和控制，监管，人类受试者和伦理，数据管理，实验室，药学，培训，社区顾问委员会联络以及所有UZ-UCSF CTU活动的咨询职能。目标1 .C。加强我们的管理和通信系统，以确保对七个拟议的CRS进行高质量的研究实施和有效监督。 目标1 .D。 管理从当前奖励到拟议的CTU结构的过渡。 目标2。在四个网络中的研究活动的领导和优先次序上为科学做出贡献：ACTG，HPTN，Incract和MTN。目标3。通过有效的外展和沟通和社区顾问委员会（CAB）参与，在CTU临床研究活动中实现有意义的社区伙伴关系。 AIM 4。与已建立的临床研究网站合作，这些临床研究网站具有可靠的能力，经验和科学生产力的记录。 管理组件：