Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplication

7.项目总结/摘要 由Ian桑内联合领导的Wits HIV研究组临床试验部门（WHRG CTU） 和海伦里斯，包括四个经验丰富的多能临床研究中心（CRS），即机智 海伦·约瑟夫医院CRS（Sharlaa Badal-Faesen博士），The Wits RHI Shandukani妇幼CRS (Dr Lee费尔利）、Wits RHI Hillbrow Health Precinct Ward 21 CRS（Sinead Delaney-Moretlwe教授）和 Wits RHI研究中心（Thesla Palanee-Phillips博士）。这四个CRS有能力进行临床 所有四个NIH网络，ACTG，IMPAACT，HPTN和VTN的试验。 CTU的研究议程包括艾滋病毒治疗，艾滋病毒相关感染和艾滋病毒相关癌症;艾滋病毒 预防;结核病治疗和预防（包括耐多药结核病）和肝炎。反恐组进行研究 在所有关键人群中，包括少女和年轻妇女，男男性行为者， 变性人口和女性性工作者;以及新生儿，婴儿， 年龄较大的儿童、孕妇和哺乳期妇女。CTU有能力进行新药研究 (IND)水平试验，包括I/II/II期试验、盲态和非盲态随机试验，范围广泛 产品，包括用于治疗和预防的口服产品;用于婴儿、儿童、青少年的疫苗， 孕妇和成人;用于治疗和预防的可注射长效抗逆转录病毒药物;单克隆 抗体注射液和杀微生物剂。每个CRS的专业知识、设施和专用设备导致 研究中心以高质量和高效率开展这些研究。CTU拥有内部实验室 能力和合同外部实验室进行测试所需的网络标准。 这四个地点位于南非繁华的城市中心约翰内斯堡， 反恐组的研究人员在约翰内斯堡招募，采用适合每个人的有针对性的方法， 确保不排除可能处于最高风险的难以接触的人。这需要设施-和 以社区为基础的招聘和反恐组有一个正式的方法，在所有社区参与 基于良好参与性做法原则的相关人群。 CTU在所有部门都有丰富的经验和专业知识，包括但不限于药房、监管部门 流程、数据管理、质量管理、培训和指导，尽管四个CRS 独特的CTU优化了所有CRS之间的效率和协作。与具体 人口在CTU内部共享，但也在南非，区域和国际上共享。 CTU已经成功完成了10多项IND审核和FDA、EMEA和SAHPRA检查; 成功的PPD和申办者检查。

7. Project Summary/Abstract The Wits HIV Research Group Clinical Trials Unit (WHRG CTU) under the joint PI Leadership of Ian Sanne and Helen Rees, includes four experienced pleuripotent Clinical Research Sites (CRSs), namely the Wits Helen Joseph Hospital CRS (Dr Sharlaa Badal-Faesen), The Wits RHI Shandukani Maternal and Child CRS (Dr Lee Fairlie), Wits RHI Hillbrow Health Precinct Ward 21 CRS (Prof. Sinead Delaney-Moretlwe) and the Wits RHI Research Centre (Dr Thesla Palanee-Phillips). These four CRSs have capacity to conduct clinical trials across all four NIH Networks, the ACTG, IMPAACT, HPTN and VTN. The CTU’s research agenda includes HIV treatment, HIV-associated infections and HIV-related cancers; HIV prevention; TB treatment and prevention (including MDR-TB) and Hepatitis. The CTU conducts research across all key populations, including adolescent girls and young women, men who have sex with men, transgender populations and female sex workers; as well as vulnerable populations such as neonates, infants, older children, pregnant and breastfeeding women. The CTU has capacity to conduct Investigational New Drug (IND) level trials including phase I/II/II trials, blinded and unblinded randomized trials, across a wide range of products including oral products for treatment and prevention; vaccines for infants, children, adolescents, pregnant women and adults; injectable long acting antiretrovirals for treatment and prevention; monoclonal antibody infusions and microbicides. The expertise, facilities and specialized equipment at each CRS results in the sites conducting these studies at a high level of quality and efficiency. The CTU has in-house laboratory capacity and contracts external laboratories to perform testing to the required Network standards. The four sites are situated in Johannesburg, South Africa’s bustling urban centre and populations included in the CTU research are recruited within Johannesburg, using a targeted approach appropriate for each, and ensuring that hard-to-engage people who may be at highest risk are not excluded. This requires facility- and community-based recruitment and the CTU has a formalized approach, for community engagement across all relevant populations based on good participatory practice principles. The CTU has substantial experience and expertise within all components including but Pharmacy, Regulatory Processes, Data Management, Quality Management, Training and Mentoring and although the four CRSs are distinct, the CTU optimizes efficiencies and collaboration across all CRSs. Experience related to specific populations is shared within the CTU, but also externally locally in South Africa, Regionally and Internationally. The CTU has had over 10 successful IND audits and inspections FDA, EMEA and SAHPRA; and numerous successful PPD and sponsor inspections.