The Johns Hopkins University-Blantyre Clinical Trials Unit

描述（由申请人提供）：撒哈拉以南非洲地区继续承受着全球艾滋病毒流行的不成比例的负担。在世界上受影响最严重的地区开展研究对国际艾滋病毒研究议程至关重要。约翰霍普金斯大学布兰太尔临床试验单位（JHU Blantyre-CTU）及其临床研究中心（CRS） 马拉维位于世界上受影响最严重的地区之一，建议继续并扩大与四个NIAID临床研究网络的高影响研究合作，以预防、治疗和管理成人、夫妇和儿童的艾滋病毒和艾滋病。凭借20多年的艾滋病毒研究经验和主办机构约翰霍普金斯大学的强大支持，CTU和CRS领导层将负责根据所有网络，NIAID和监管政策协调和执行布兰太尔CRS的临床试验。CTU旨在通过以下方式推进拟议的临床研究网络的科学议程：生成和开发新的科学概念;在当前CTU下，继续在布兰太尔的CRS实施积极的研究方案;以及通过具备快速参与方案特定研究中心的能力和流程，以应对新兴的网络需求。反恐组在努力实现这些目标时，将强调所有行动的质量、监督、凝聚力和效率。目前，布兰太尔研究中心参与了艾滋病/NIAID临床研究网络四个现有分部从开始到完成的26项不同阶段的研究。CRS建立了有效的合作关系，并通过社区咨询小组的使用，让代表当地社区需求和研究优先事项的成员参与进来。本申请的目的是描述拟议的JHU-Blantyre CRS的科学、领导和管理优势，这将确保NIAID国际临床研究议程的成功实施。本申请的10个组成部分提供了对拟议CTU的科学概述，并描述了其行政和财务管理结构;沟通和评估计划;以及布兰太尔CRS每个技术部门的人员和资源，包括社区参与、药房、实验室、质量和监管保证以及数据管理。 相关性：拟议的约翰霍普金斯大学-布兰太尔临床试验单位（CTU）及其位于马拉维布兰太尔的临床研究中心（CRS）拥有专业知识、经验、基础设施和承诺，可为四个NIAID临床研究网络的科学议程做出贡献。在过去的20年里，包括当前CTU周期的6年，CRS与社区建立了牢固的关系，以确保获得适当的研究人群。CTU首席研究员通过其领导力和广泛的研究相关资源得到了主办机构约翰霍普金斯大学的大力支持。

DESCRIPTION (provided by applicant): 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 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 and manage HIV and AIDS in adults, couples and children. With more than 20 years of HIV research experience and the strong backing of the host institution, Johns Hopkins University, the CTU and CRS leadership will be responsible for the coordination and execution of clinical trials at the Blantyre CRS in accordance with all Network, NIAID and regulatory policies. The CTU aims to advance the scientific agenda of the proposed Clinical Research Networks by generating and developing new scientific concepts; continuing implementation of the active study protocols at the CRS in Blantyre under the current CTU; and by having the capacity and processes in place to quickly engage protocol-specific research sites to respond to emerging Network needs. The CTU will emphasize quality, oversight, cohesiveness and efficiency in all operations as it works to achieve these aims. Currently, the Blantyre CRS is involved in 26 studies at various stages, from initiation to completion, for four existing Divisionof AIDS/NIAID Clinical Research Networks. The CRS has established effective collaborations and engaged constituents representing the needs and research priorities of the local communities through the use of Community Advisory Group. The goal of this application is to describe scientific, leadership and administrative strengths of the proposed JHU-Blantyre CRS which will ensure successful implementation of the NIAID international clinical research agenda. The ten components of this application provide a scientific overview of the proposed CTU and describe its administrative and financial management structures; plans for communication and evaluation; and the personnel and resources of each technical department of the Blantyre CRS, including community engagement, pharmacy, laboratory, quality and regulatory assurance, and data management. RELEVANCE: The proposed Johns Hopkins University-Blantyre Clinical Trials Unit (CTU) and its Clinical Research Site (CRS) in Blantyre, Malawi have the expertise, experience, infrastructure and commitment to contribute to the scientific agendas of four NIAID Clinical Research Networks. Over the past 20 years, including 6 years in the current CTU cycle, the CRS has built strong relationships with the community to ensure access to appropriate study populations. The CTU Principal Investigator is strongly supported by the host institution, the Johns Hopkins University through its leadership and wide array of research-related resources.