University of Cape Town Clinical Trials Unit (UCTCTU)

描述（申请人提供）：开普敦大学临床试验部门（UCTCTU）将成功满足美国国立卫生研究院和相关临床试验网络的科学需求，原因如下：CTU拥有6个完善的多样化临床研究中心，由经验丰富的团队领导，并有能力应对艾滋病毒的流行，结核病及相关疾病的预防和治疗研究涉及广泛的人群，包括MSM和青少年等重点人群。 这些临床研究中心位于艾滋病毒、结核病、性传播感染和非传染性疾病负担与世界上任何地方一样高或更高的社区。两个临床研究中心已经 DAIDS获得认证，其他4个网站是由一系列其他公认的网络赞助的功能强大的网站。UCTCTU及其研究中心位于南非的一个省，该省有一个运作良好的合作卫生部门。这些地点都可以使用一些最好的实验室，可以说是该国最好的科学专业知识和最好的医疗诊断和调查资源。CTU由一所被评为非洲最好的大学的机构和一所最近在全球排名前50位的健康科学学院提供住宿和支持。这个令人兴奋和广泛的临床研究中心联盟的效率和协同作用是由所有研究中心都是开普敦大学的组成部分这一事实引起的，因此拥有一个共享的管理平台，所有研究中心和CTU核心都在很短的车程内。在这次重新申请中，DTHC经验丰富的团队将合作扩展到UCT健康科学学院的其他成熟的临床研究小组，并将CTU扩展到拟议的UCTCTU，该UCTCTU将为6个研究中心和5个网络提供服务，此外，还对抗菌素耐药性感兴趣。 相关性：UCT临床试验部门在开普敦及其周边地区设有6个多能临床研究中心，将能够通过在治疗、预防和管理艾滋病毒、结核病及相关感染和疾病方面开展出色的临床试验和研究，为国际和NIH的科学议程做出贡献。这一对治疗和预防艾滋病毒/结核病的新的和改进的方法的全球性探索也将对开普敦负担沉重的社区的个人生活产生重大影响。

DESCRIPTION (provided by the applicant): The University of Cape Town Clinical Trials Unit (UCTCTU) will successfully contribute to the scientific needs of the National Institutes of Health and associated Clinical Trial Networks for the following significant reasons: The CTU presents 6 well established diverse clinical research sites led by an experienced team and an ability to respond to the epidemics of HIV, TB and associated conditions in both prevention and treatment research involving a broad range of populations including key populations such as MSM and adolescents. The clinical research sites exist in communities where the burden of HIV, TB, STI and non-communicable disease are as high as or higher than anywhere in the world. Two of the clinical research sites are already DAIDS accredited and the other 4 are highly functional sites sponsored by a range of other well-recognized networks. The UCTCTU and its research sites occur in one South African province with a well-functioning, cooperative health department. The sites all have access to some of the best laboratories, and arguably the finest scientific expertise and best medical diagnostic and investigative resources in the country. The CTU is accommodated and supported by an institution ranked the best university in Africa and a Health Science faculty recently ranked in the top 50 worldwide. The efficiencies and synergies of this exciting and broad reaching consortium of clinical sites is invoked by the fact that all the sites are components of the University of Cape Town thus having a shared management platform and all sites and CTU core are within a short drive. In this re-application, the experienced team at the DTHC has extended collaborations to other well established clinical research groups in the Health Science Faculty at UCT and expanded the CTU to the proposed UCTCTU which will service 6 research sites and 5 networks with, in addition, an interest in antimicrobial resistance. RELEVANCE: The UCT Clinical Trials Unit is described here with 6 pluripotent Clinical Research Sites in and around Cape Town will be able to contribute to the international and NIH scientific agenda by conducting excellent clinical trials and research in treatment, prevention and management of HIV, TB and related infections and conditions. This globally relevant quest for novel and improved ways to treat and prevent HIV/TB will also significantly impact the lives of individuals in the heavily burdened communities in Cape Town.