KwaZulu-Natal Clinical Trials Unit

夸祖鲁-纳塔尔省临床试验单位

• 批准号: 10526404
• 负责人: QUARRAISHA ABDOOL KARIM
• 金额: $ 210.45万
• 依托单位: CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10526404
• 关键词: AIDS prevention; Accreditation; Acquired Immunodeficiency Syndrome; Adolescent; Adult; Africa; Antibodies; Breast Feeding; Cessation of life; Child; Childhood; Clinical; Clinical Trials; Clinical Trials Network; Clinical Trials Unit; Communication; Communication Tools; Communities; 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; Health Services; Incidence; Individual; Infection; Influentials; Injectable; International Maternal Pediatric Adolescent AIDS Clinical Trials; Journals; Laboratories; Laboratory Technicians; Leadership; Medical Research; Medicine; Monitor; 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; Viral Load result; Virus; Vision; Work; clinical research site; clinical trial implementation; cohort; community engagement; data management; experience; high risk population; innovation; meetings; mortality; mosaic; neutralizing antibody; novel; novel strategies; organizational structure; point of care; pre-exposure prophylaxis; programs; quality assurance; retention rate; service providers; skills; sound; symposium; transmission process; treatment optimization; treatment strategy; treatment trial; vaccine immunogenicity; vaccine trial; vaginal microbiome; web site; working group; young woman

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.

总结- KZN-CTU