Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplication

7.项目摘要/摘要 由Ian Sanne联合领导的Wits HIV研究小组临床试验单位(WHRG CTU) 和海伦·里斯，包括四个经验丰富的多效性临床研究网站(CRSS)，即Wits 海伦·约瑟夫医院CRS(Sharlaa Badal-Fesen医生)、Wits RHI Shandukani母婴CRS (Lee Fairlie医生)，Wits Rhi Hillbrow卫生区21 CRS(Sinead Delaney-Moretlwe教授)和 WITS RHI研究中心(特斯拉·帕拉尼-菲利普斯博士)。这四个CRS都有能力进行临床 在所有四个NIH网络、ACTG、IMPAACT、HPTN和VTN上进行试验。 反恐联盟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； 预防；结核病治疗和预防(包括耐多药结核病)和肝炎。CTU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。反恐组有能力进行新药调查 (IND)水平试验，包括I/II/II阶段试验、盲法和非盲法随机试验，涉及广泛的 产品包括治疗和预防用口服产品；婴儿、儿童、青少年疫苗， 孕妇和成人.治疗和预防用可注射长效抗逆转录病毒药物.单抗 抗体输注和杀微生物剂。每个CRS的专业知识、设施和专门设备导致 以高质量和高效率进行这些研究的站点。CTU有自己的实验室 能力，并与外部实验室签订合同，按照所需的网络标准进行测试。 这四个地点位于南非繁华的城市中心约翰内斯堡，人口包括在 反恐联盟的研究是在约翰内斯堡内部招募的，采用了适合每个人的有针对性的方法，以及 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--以及 社区招募和反恐联盟有一种正式的方法，让所有人都参与社区活动 以良好的参与性实践原则为基础的相关人群。 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CRSS是 不同的是，CTU优化了所有CRS的效率和协作。与特定项目相关的经验 人口在反恐联盟内部共享，但在南非的外部、区域和国际上也是本地共享的。 CTU已经成功地进行了10多次IND审计和检查，包括FDA、EMEA和SAHPRA；以及 PPD和赞助商检查成功。

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.