KwaZulu-Natal Clinical Trials Unit

夸祖鲁-纳塔尔省临床试验单位

• 批准号: 10526404
• 负责人: QUARRAISHA ABDOOL KARIM
• 金额: $ 210.45万
• 依托单位: CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA
• 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 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10526404
• 关键词: AIDS prevention; Accreditation; Acquired Immunodeficiency Syndrome; Adolescent; Adult; Africa; Antibodies; Breast Feeding; Cessation of life; Child; Childhood; Clinical; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Communication; Communication Tools; Communities; Conduct Clinical Trials; Country; Data; Data Management Resources; Decision Making; Development; Enrollment; Ensure; Epidemic; Evaluation; Fostering; Funding; Generations; Goals; Good Clinical Practice; HIV; HIV Vaccine Trials Network; HIV prevention trial; HIV vaccine; HIV/TB; Health; Health Services; Incidence; Individual; Infection; Influentials; Injectable; International Maternal Pediatric Adolescent AIDS Clinical Trials; Journals; Laboratories; Laboratory Technicians; Leadership; Medical Research; Medicine; Monitor; Nevirapine; New England; Newsletter; Nurses; Occupational activity of managing finances; Oral; Participant; Persons; Pharmacists; Pharmacy facility; Phase; Policies; Politics; Population; Population Heterogeneity; Pregnant Women; Prevalence; Prevention; Prevention strategy; Prevention therapy; Prophylactic treatment; Protocols documentation; Province; Public Health; Publications; Reporting; Research; Research Personnel; Research Priority; Research Support; Resources; Role; Safety; Science; Scientist; Seminal; Site; South Africa; South African; Target Populations; Technology; Tenofovir; Training; Travel; Tuberculosis; Tuberculosis Vaccines; United Nations; Viral Load result; Virus; Vision; Work; clinical research site; clinical trial implementation; cohort; community engagement; data management; experience; high risk population; innovation; meetings; mortality; mosaic; neutralizing antibody; novel; novel strategies; organizational structure; point of care; pre-exposure prophylaxis; programs; quality assurance; retention rate; service providers; skills; sound; symposium; transmission process; treatment optimization; treatment strategy; treatment trial; vaccine immunogenicity; vaccine trial; vaginal microbiome; web site; working group; young woman

Summary – KZN-CTU The KwaZulu-Natal Clinical Trials Unit (KZN-CTU), strategically located in the epicentre of one of the world’s most severe HIV and tuberculosis epidemics, seamlessly combines the Clinical Research Sites (CRSs) of existing, high-performing CTUs at CAPRISA and the South African Medical Research Council (SAMRC). In the current funding cycle, the combined CTUs enrolled 4,713 participants in 28 protocols, with an overall retention rate of 93%. Further, several KZN-CTU scientists participated at the highest levels in the Clinical Trial Networks (CTNs), making influential new scientific contributions, including as network Protocol Chairs, that have impacted global policy/practice, including tenofovir-containing PrEP for HIV prevention, co-treatment strategies to reduce HIV-tuberculosis deaths and nevirapine prophylaxis to reduce breastfeeding transmission. This renewal application’s goal is to make even greater contributions to the scientific priorities of all 4 CTNs through novel research concepts, innovative prevention technologies (eg. CAPRISA 256 antibody) and high-quality clinical trials in high priority populations by experienced research teams at well-equipped CRSs. The KZN-CTU, led by Quarraisha Abdool Karim of CAPRISA, comprises 4 components: i) Leadership and governance, ii) Coordination and monitoring, and iii) 8 CRSs, supported by iv) 8 research support cores. The Leadership and governance component will ensure effective CTU decision-making and governance, active engagement with each CTN and oversee the efficient functioning of the CTU. The Coordination and monitoring component is responsible for coordination of clinical trial implementation at high quality. The 8 CRSs, with HIV incidence rates ranging from 4.6 to 8.2 per 100 person-years in recent trials, are in the highest burden districts of South Africa with diverse populations suited to HIV prevention, vaccine and treatment trials as well as trials in children, adolescents and pregnant women. The Support Cores work with all the CRSs providing assistance in the conduct of clinical trials, with administration and financial resource management, communication, evaluation, training and quality assurance, community engagement, pharmacy, laboratory, data management and IT, and regulatory compliance. The CTU’s organizational structures (Leadership Group, Executive Committee and Community Advisory Boards) and communication tools (regular meetings, video conferences, monthly newsletters and an informative website) enable effective communication, coordination and governance in the unit. The KZN-CTU has groundswell support from KwaZulu-Natal community groups and high-level political backing of the National and Provincial Departments of Health. Overall, the KZN-CTU has well-characterized high-risk populations, well-established clinical facilities, accredited laboratories, pharmacies, and data management systems, strong community linkages, and extensive experience in conducting clinical trials, together with a track record of scientific innovation available to support all 4 CTNs in developing new approaches to HIV and tuberculosis prevention and treatment.

摘要 – KZN-CTU 夸祖鲁-纳塔尔省临床试验中心 (KZN-CTU) 战略性地位于夸祖鲁-纳塔尔省临床试验中心之一 世界上最严重的艾滋病毒和结核病流行病，无缝结合临床研究中心（CRS） CAPRISA 和南非医学研究委员会 (SAMRC) 现有的高性能 CTU。在 在当前的资助周期中，合并后的 CTU 在 28 个协议中招募了 4,713 名参与者，总体而言 保留率93%。此外，几位 KZN-CTU 科学家以最高级别参与了临床试验 网络（CTN），做出有影响力的新科学贡献，包括作为网络协议主席， 影响了全球政策/实践，包括用于艾滋病毒预防、联合治疗的含替诺福韦的 PrEP 减少艾滋病毒结核病死亡的策略和奈韦拉平预防措施以减少母乳喂养传播。 此更新应用程序的目标是为所有 4 个领域的科学优先事项做出更大的贡献 通过新颖的研究理念、创新的预防技术（例如 CAPRISA 256 抗体）和 由经验丰富的研究团队在设备精良的 CRS 中对高优先人群进行高质量的临床试验。 KZN-CTU 由 CAPRISA 的夸莱沙·阿卜杜勒·卡里姆 (Quarraisha Abdool Karim) 领导，由 4 个组成部分组成： i) 领导力和 治理，ii) 协调和监测，以及 iii) 8 个 CRS，由 iv) 8 个研究支持核心支持。 领导和治理部分将确保 CTU 的有效决策和治理， 积极参与每个 CTN 并监督 CTU 的有效运作。协调和 监测部门负责协调临床试验的高质量实施。 8号 在最近的试验中，CRS 的 HIV 发病率为每 100 人年 4.6 至 8.2 例，处于最高水平 南非各地区的不同人群适合进行艾滋病毒预防、疫苗和治疗试验 以及针对儿童、青少年和孕妇的试验。支持核心可与所有 CRS 配合使用 为临床试验的进行提供行政和财务资源管理方面的协助， 沟通、评估、培训和质量保证、社区参与、药房、实验室、 数据管理和 IT 以及法规遵从性。 CTU 的组织结构（领导小组、 执行委员会和社区咨询委员会）和沟通工具（定期会议、视频 会议、月度通讯和信息网站）促进有效的沟通、协调 以及单位内的治理。 KZN-CTU 得到了夸祖鲁-纳塔尔省社区团体的大力支持 以及国家和省卫生部门的高层政治支持。 总体而言，KZN-CTU 拥有特征明确的高危人群、完善的临床设施、 认可的实验室、药房和数据管理系统、强大的社区联系，以及 进行临床试验的丰富经验以及可用的科学创新记录 支持所有 4 个 CTN 开发艾滋病毒和结核病预防和治疗的新方法。