The Johns Hopkins University-Blantyre Clinical Trials Unit

项目摘要 撒哈拉以南非洲继续承受着全球艾滋病毒流行的不成比例的负担。正在进行 在世界上受影响最严重的地区进行研究对国际艾滋病毒研究议程至关重要。约翰斯一家 霍普金斯大学马拉维布兰太尔临床试验中心(JHU Blantyre-CTU)及其临床研究网站(CRS) 在马拉维，位于世界上受影响最严重的地区之一，建议继续并扩大高- 与四个NIAID临床研究网络合作进行Impact研究以预防、治疗和管理 并有可能治愈成人、关键人群和儿童中的艾滋病毒和艾滋病。带着30多年的艾滋病毒 研究经验和主办机构的大力支持(约翰·霍普金斯大学和#年学院 马拉维大学医学院)，CTU和CRS领导层将负责进行和 根据研究网络和NIAID管理CRS布兰太尔的临床试验 政策。CTU旨在推进拟议的艾滋病毒临床研究网络的科学议程 成人和儿童的预防、治疗和疫苗研究 发展新的科学概念；在布兰太尔CRS继续执行积极的研究方案 在当前的CTU下；提供高效和灵活的当地研究基础设施，以迅速 满足网络新出现的需求；并让特定于议定书的人群参与进来。CTU将会 在所有业务中强调质量、监督、凝聚力和效率，以实现这些目标。 在本CTU周期内(2013年至今)，布兰太尔研究报告参与了35项不同的研究 现有的四个艾滋病/NIAID临床研究网络司从启动到完成的各个阶段。这个 CRS已经建立了有效的机构和社区合作，并对 马拉维的网络议程和国家卫生研究议程。此应用程序的目标是 描述拟议的JHU-Blantyre CTU及其CRS在科学、领导和管理方面的优势 马拉维布兰太尔，这将确保成功实施NIAID国际临床研究 议程。本申请的各小节(A-L)提供了对拟议的CTU和 说明其行政和财务管理结构；沟通、评价和 培训；以及CTU各组成部分和CRS技术部门的作用、职责和资源， 包括社区参与、药房、实验室、质量和监管保证以及数据 管理层。我们的CTU安排包括一个CRS，已经证明了能力和 提高效率。

Project Summary Sub-Saharan Africa continues to bear a disproportionate burden of the global HIV epidemic. Conducting studies in the most affected areas of the world is critical to the international HIV research agenda. The Johns Hopkins University-Blantyre, Malawi Clinical Trials Unit (JHU Blantyre-CTU) and its clinical research site (CRS) in Malawi, located in one of the most affected regions of the world, propose to continue and expand high- impact research collaborations with four NIAID Clinical Research Networks in order to prevent, treat, manage and potentially cure HIV and AIDS in adults, key populations, and children. With more than 30 years of HIV research experience and the strong backing of the host institutions (Johns Hopkins University and College of Medicine, University of Malawi), the CTU and CRS leadership will be responsible for the conduct and management of clinical trials at the Blantyre, CRS in accordance with the Research Networks and NIAID policies. The CTU aims to advance the scientific agenda of the proposed Clinical Research Networks for HIV prevention, treatment and vaccine research among adults and children by generating hypotheses and developing new scientific concepts; continuing implementation of active study protocols at the Blantyre CRS under the current CTU; making available the efficient and flexible local research infrastructure to quickly respond to emerging needs of the Networks; and by engaging protocol-specific populations. The CTU will emphasize quality, oversight, cohesiveness and efficiency in all operations as it works to achieve these aims. During the current CTU cycle (2013 to present), the Blantyre CRS has been involved in 35 studies at various stages, from initiation to completion, for four existing Division of AIDS/NIAID Clinical Research Networks. The CRS has established effective institutional and community collaborations and has been responsive to both the Network agendas and the national health research agenda for Malawi. The goal of this application is to describe scientific, leadership and administrative strengths of the proposed JHU-Blantyre CTU and its CRS in Blantyre, Malawi, which will ensure successful implementation of the NIAID international clinical research agenda. The sub-sections (A-L) of this application provide a scientific overview of the proposed CTU and describe its administrative and financial management structures; plans for communication, evaluation and training; and the roles, responsibilities and resources of each CTU element and CRS technical department, including community engagement, pharmacy, laboratory, quality and regulatory assurance, and data management. Our CTU arrangement that encompasses a single CRS has demonstrated capacity and promotes efficiency.