Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplication

Wits HIV 研究小组临床试验单位 (CTU) 重新申请

• 批准号: 10057407
• 负责人: Helen Rees
• 金额: $ 187.75万
• 依托单位: WITS HEALTH CONSORTIUM (PTY), LTD
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-15 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10057407
• 关键词: AIDS clinical trial group; AIDS prevention; AIDS/HIV problem; Adolescent; Adult; Blinded; Breast Feeding; Child; Childhood; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Network; Clinical Trials Unit; Collaborations; Communities; Conduct Clinical Trials; Contracts; Data; Development; Elements; Ensure; Epidemic; Equipment; Ethics; Female Adolescents; Funding; Good Clinical Practice; HIV; HIV prevention trials network; Health; Hepatitis; Hospitals; Individual; Infant; Infection; Infrastructure; Infusion procedures; Injectable; Institution; International; International Maternal Pediatric Adolescent AIDS Clinical Trials; Investigational Drugs; Joints; Laboratories; Leadership; Legal; Malignant Neoplasms; Medicine; Mentors; Monoclonal Antibodies; Morbidity - disease rate; Multidrug-Resistant Tuberculosis; National Institute of Allergy and Infectious Disease; Occupational activity of managing finances; Office of Administrative Management; Oral; Pharmacy facility; Phase; Policies; Population; Pregnant Women; Prevention; Prevention Research; Procedures; Process; Reapplication; Research; Research Activity; Research Infrastructure; Research Personnel; Sampling; Site; South Africa; Structure; Testing; Therapeutic; Training; Tuberculosis; U-Series Cooperative Agreements; United States National Institutes of Health; VTN gene; Vaccines; Vulnerable Populations; Wit; Woman; antiretroviral therapy; base; clinical center; clinical development; clinical research site; cohesion; community engagement; comorbidity; data access; data management; experience; female sex worker; high risk; high standard; men who have sex with men; microbicide; mortality; neonate; patient population; population based; pregnant; randomized trial; recruit; study population; transgender; transmission process; treatment research; tuberculosis treatment; vaccine trial; ward; young woman

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.

7. 项目总结/摘要 Wits HIV 研究小组临床试验单位 (WHRG CTU) 在 Ian Sanne 的联合 PI 领导下 和 Helen Rees，包括四个经验丰富的多能临床研究中心 (CRS)，即 Wits Helen Joseph 医院 CRS（Sharlaa Badal-Faesen 博士）、The Wits RHI Shandukani 妇幼 CRS （Lee Fairlie 博士）、Wits RHI Hillbrow 健康区 21 病房 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 在所有四个 NIH 网络（ACTG、IMPAACT、HPTN 和 VTN）上进行试验。 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；艾滋病病毒 预防;结核病治疗和预防（包括耐多药结核病）和肝炎。 CTU 开展研究 所有关键人群，包括少女和年轻女性、男男性行为者、 变性人群和女性性工作者；以及新生儿、婴儿等弱势群体， 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、盲法和非盲法随机试验，涉及范围广泛 产品，包括用于治疗和预防的口腔产品；婴儿、儿童、青少年疫苗， 孕妇和成人；用于治疗和预防的注射长效抗逆转录病毒药物；单克隆 抗体输注和杀菌剂。每个 CRS 的专业知识、设施和专业设备导致 这些研究中心以高质量和高效率进行这些研究。 CTU拥有内部实验室 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 CTU 研究人员在约翰内斯堡招募，采用适合每个项目的有针对性的方法，并且 确保那些可能面临最高风险的难以参与的人不被排除在外。这需要设施和 基于社区的招聘，CTU 拥有正式的方法，让社区参与所有领域 基于良好参与实践原则的相关人群。 CTU 在所有领域都拥有丰富的经验和专业知识，包括制药、监管 流程、数据管理、质量管理、培训和指导，尽管这四个 CRS 是 与众不同的是，CTU 优化了所有 CRS 之间的效率和协作。与特定相关的经验 人口在 CTU 内部共享，但也在南非本地、区域和国际范围内共享。 CTU 已成功完成 10 多次 FDA、EMEA 和 SAHPRA 的 IND 审核和检查；和无数的 成功的 PPD 和申办者检查。