KwaZulu-Natal Clinical Trials Unit

夸祖鲁-纳塔尔省临床试验单位

基本信息

批准号：
10057406
负责人：
QUARRAISHA ABDOOL KARIM
金额：
$ 306.01万
依托单位：
CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA
依托单位国家：
美国
项目类别：
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/10057406
关键词：
AIDS prevention Accreditation Acquired Immunodeficiency Syndrome Adolescent Adult Africa Antibodies Back Breast Feeding Cessation of life Child Childhood Clinical Clinical Trials Clinical Trials Network Clinical Trials Unit Communication Communication Tools Communities Community Health Services 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 Incidence Individual Infection Influentials Injectable International Maternal Pediatric Adolescent AIDS Clinical Trials Journals Laboratories Laboratory Technicians Leadership Medical Research Medicine Monitor Mosaicism 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 Ursidae Family Videoconferencing Viral Load result Virus Vision Work base clinical research site clinical trial implementation cohort community engagement data management experience high risk population immunogenicity innovation meetings mortality neutralizing antibody novel novel strategies organizational structure point of care pre-exposure prophylaxis programs quality assurance retention rate service providers sound transmission process treatment optimization treatment strategy treatment trial vaccine trial vaginal microbiome web site working group young woman

项目摘要

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 - 纳塔尔临床试验单元（KZN-CTU），策略地位于其中一个的中心世界上最严重的艾滋病毒和结核病流行病，无缝地结合了临床研究地点（CRSS） Caprisa和南非医学研究委员会（SAMRC）现有的高性能TU。在当前的筹资周期，组合的CTU在28个方案中招募了4,713名参与者，总体保留率为93％。此外，几位KZN-CTU科学家参加了临床试验的最高水平网络（CTN），做出有影响力的新科学贡献，包括作为网络协议椅，已经影响了全球政策/实践，包括预防艾滋病毒的预防准备，共同治疗减少HIV - 核核病死亡和预防奈韦拉平的策略，以减少母乳喂养的传播。该更新申请的目标是为所有4个的科学重点做出更大的贡献 CTN通过新颖的研究概念，创新的预防技术（例如Caprisa 256抗体）和设备齐全的CRS的经验丰富的研究团队在高优先级人群中进行的高质量临床试验。由Caprisa的Quarraisha Abdool Karim领导的KZN-CTU组成了4个组成部分：i）领导力和治理，ii）协调和监测，以及III）8 CRS，由IV）支持8研究支持核心。领导和治理部分将确保有效的CTU决策和治理，与每个CTN的主动互动并监督CTU的有效功能。协调和监视部分负责高质量的临床试验实施协调。 8 在最近的试验中，CRS的艾滋病毒发病率在每100人年为4.6至8.2 南非的负担地区有适合预防艾滋病毒，疫苗和治疗试验的潜水员人群以及儿童，青少年和孕妇的试验。支持核与所有CRS一起使用在进行临床试验，管理和财务资源管理方面提供帮助，沟通，评估，培训和质量保证，社区参与，药房，实验室，数据管理及IT以及法规合规性。 CTU的组织结构（领导力小组，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，每月新闻通讯和内容丰富的网站）实现有效的沟通，协调和部门的治理。 KZN-CTU获得了夸祖鲁 - 纳塔尔社区团体的基础支持以及国家和省级卫生部门的高级政治支持。总体而言，KZN-CTU具有良好的高风险人群，良好的临床设施，认可的实验室，药房和数据管理系统，牢固的社区联系以及在进行临床试验方面的丰富经验，以及科学创新的记录支持所有4个CTN开发新的HIV和结核病预防和治疗方法。