KwaZulu-Natal Clinical Trials Unit

摘要-KZN-CTU 夸祖鲁-纳塔尔临床试验单位(KZN-CTU)，战略上位于 世界上最严重的艾滋病毒和结核病流行，无缝结合临床研究网站(CRSS) 非洲医学研究中心(CAPRISA)和南非医学研究理事会(SAMRC)现有的高绩效CTU。在……里面 在本供资周期，合并后的反恐股在28个方案中招募了4713名参与者，总体 保留率达93%。此外，KZN-CTU的几位科学家以最高级别参与了临床试验 网络(CTN)，作出有影响力的新科学贡献，包括担任网络协议主席， 影响了全球政策/做法，包括用于艾滋病毒预防、共同治疗的含替诺福韦的PrEP 减少艾滋病毒-结核病死亡的战略和预防奈韦拉平以减少母乳传播的战略。 这项续订申请的目标是为所有4个国家的科学优先事项做出更大贡献 通过新的研究概念、创新的预防技术(例如，CAPRISA 256抗体)和 由装备精良的CRSS的经验丰富的研究团队在高优先级人群中进行高质量的临床试验。 KZN-CTU由CAPRISA的Quarraisha Abdool Karim领导，由4个组成部分组成：一)领导和 管理，二)协调和监测，三)8个中央支助办公室，由4)8个研究支助核心提供支持。 领导和治理部分将确保反恐联盟有效的决策和治理， 积极参与每个反恐小组的工作，并监督反恐小组的有效运作。协调与合作 监测部分负责协调高质量的临床试验实施。前8名 在最近的试验中，CRSS的艾滋病毒发病率从每100人年4.6到8.2人不等，是最高的 南非的负担地区，有适合艾滋病毒预防、疫苗和治疗试验的不同人群 以及在儿童、青少年和孕妇身上进行的试验。支持核心与所有CRSS协同工作 协助进行临床试验，进行行政和财政资源管理， 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。反恐联盟的组织结构(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、月刊和信息量大的网站)使有效的沟通、协调 以及对单位的治理。KZN-CTU得到了夸祖鲁-纳塔尔社区团体的大力支持 以及国家和省卫生厅的高层政治支持。 总体而言，KZN-CTU拥有特征明确的高危人群，完善的临床设施， 经认可的实验室、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，以及现有的科学创新记录 支持所有4个社区卫生网络制定艾滋病毒和结核病预防和治疗的新方法。

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.