Johns Hopkins AIDS Clinical Trials Unit

描述(由申请人提供)： 约翰霍普金斯大学是国内和国际艾滋病毒临床研究的领先者。拟议中的约翰霍普金斯大学艾滋病临床试验小组(CTU)将汇集三个独立资助的艾滋病毒临床研究小组，执行(1)成人和(2)儿科治疗试验，以及(3)艾滋病毒预防研究。这三个小组将组成一个统一的CTU，为东巴尔的摩的约翰·霍普金斯医疗机构的一个临床研究站点(CRS)的三个DAIDS临床研究网络提供服务。该网站将隶属于拟议的(1)艾滋病临床试验小组(ACTG)网络，(2)国际母婴青少年艾滋病临床试验网络(IMPAACT)，(3)艾滋病毒预防试验网络(HPTN)。 我们对DAIDS科学议程做出实质性贡献的历史由来已久，特别是在预防和治疗试验、早期药物开发和实验疗法、神经病学、肝炎病毒和艾滋病毒联合感染以及儿科、青少年和母婴研究等领域。在过去的五年里，这个提议中的CTU的调查人员已经发表了1000多篇与艾滋病毒感染有关的论文，其中300篇是这样的。这些调查人员作为首席调查员或联合首席调查员持有21笔与艾滋病毒有关的国家卫生研究院资助的赠款，每年的直接成本超过700万美元。我们现有的成人ACTG单位在招募非裔美国人和妇女方面排名全国第一，他们中的许多人都有药物滥用史。数据管理被评为优秀，科目留存堪称典范。CRS将从附属诊所招聘，为30,000多名艾滋病毒感染者和高危人群提供服务。这一新的反恐股将汇聚一大批经验丰富、有很强合作历史的调查人员，并将整合监管事务、数据管理、外联和招聘方面的行政资源。在保留我们目前艾滋病毒临床试验结构的成功方面的同时，这次重组将通过提供一个集中的、共享的管理核心而使该机构受益，这将允许规模经济，这是约翰·霍普金斯大学以前不可能实现的。最重要的是，这三个群体的结合将提供从出生到青春期到成年和衰老的跨年龄段的艾滋病毒预防和治疗研究。这个CTU处于有利地位，可以继续为国内和国际艾滋病毒临床研究做出广泛和实质性的贡献，同时也服务于其社区。 管理组件：

DESCRIPTION (provided by applicant): The Johns Hopkins University is a national and international leader in HIV clinical research. The proposed Johns Hopkins University AIDS Clinical Trials Unit (CTU) will bring together three independently funded HIV clinical research groups that perform (1) adult and (2) pediatric treatment trials, and (3) HIV prevention research. These three groups will form a unified CTU serving three DAIDS clinical research networks at one Clinical Research Site (CRS), The Johns Hopkins Medical Institutions in East Baltimore. The Site will be affiliated with the proposed (1) AIDS Clinical Trials Group (ACTG) Network, (2) International Maternal Pediatric Adolescent AIDS Clinical Thais (IMPAACT) Network, (3) HIV Prevention Trials Network (HPTN). We have a long history of substantive contribution to the DAIDS scientific agenda, especially in the areas of prevention and treatment trials, early phase drug development and experimental therapeutics, neurology, hepatitis virus and HIV co-infection, and pediatric, adolescent, and maternal-fetal research. The investigators in this proposed CTU have authored over 1,000 published papers related to HIV infection, >300 of these in the past five years. The same investigators hold 21 HIV-related NIH-funded grants as Principal Investigator or Co-Principal Investigator for over $7,000,000 in annual direct costs. Our existing Adult ACTG Unit ranks first nationally in recruitment of African-Americans and women, many of whom have a history of substance abuse. Data management is rated outstanding, and subject retention is exemplary. The CRS will recruit from affiliated clinics serving more than 30,000 HIV-infected and at-risk persons. This new CTU will bring together a large group of accomplished investigators with a strong history of collaboration, and will allow consolidation of administrative resources for regulatory affairs, data management, outreach, and recruitment. While preserving the successful aspects of our current HIV clinical trials structure, this reorganization will benefit the institution by providing a centralized, shared administrative core, which will allow an economy of scale that has not previously been possible at Johns Hopkins. Above all, the joining together of these three groups will provide access to HIV prevention and treatment research across the age spectrum, from birth to adolescence to adulthood and senescence. This CTU is well-positioned to continue its broad and substantial contributions to national and international HIV clinical research, while also serving its community. ADMINISTRATIVE COMPONENT: