Johns Hopkins AIDS Clinical Trials Unit

约翰·霍普金斯大学艾滋病临床试验中心

• 批准号: 7096301
• 负责人: Charles W. Flexner
• 金额: $ 103.49万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-05 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7096301
• 关键词: AIDS clinical trial group; AIDS prevention; Acquired Immunodeficiency Syndrome; Adolescence; Adolescent; Adult; African American; Age; Area; Baltimore; Birth; Childhood; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Direct Costs; Experimental Drug Development; Fetal Research; Funding; Grant; HIV; HIV Infections; HIV prevention trials network; Hepatitis Viruses; Infection; Institution; International; Medical; Neurology; Paper; Personal Satisfaction; Persons; Phase; Positioning Attribute; Prevention; Prevention Research; Principal Investigator; Publishing; Rate; Recording of previous events; Recruitment Activity; Regulatory Affairs; Research; Research Personnel; Resources; Risk; Site; Structure; Substance abuse problem; Therapeutic; Universities; Woman; clinical research site; data management; outreach; senescence; treatment trial

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:

描述（由申请人提供）： 约翰·霍普金斯大学（Johns Hopkins University）是艾滋病毒临床研究的国家和国际领导者。拟议的约翰·霍普金斯大学艾滋病临床试验部（CTU）将汇集三个独立资助的HIV临床研究小组，这些研究小组（1）成人和（2）儿科治疗试验，以及（3）HIV预防研究。这三个组将在一个临床研究地点（CRS），东巴尔的摩的约翰·霍普金斯医疗机构（Johns Hopkins）医疗机构，组成一个统一的CTU，为三个daids临床研究网络提供服务。该站点将隶属于拟议的（1）AIDS临床试验组（ACTG）网络，（2）国际母亲小儿青少年艾滋病临床thais（Incract）网络，（3）HIV预防试验网络（HPTN）。 我们对DAIDS科学议程有实质性贡献的历史，尤其是在预防和治疗试验的领域，早期药物开发和实验治疗学，神经病学，肝炎病毒和HIV共同感染，以及儿科，青少年和母体宠物研究。该提议的CTU中的研究人员撰写了与HIV感染有关的1,000多篇发表的论文，其中> 300个在过去五年中。同一位研究人员持有21名与HIV相关的NIH资助的赠款，作为首席研究员或联合主管调查员的年度直接费用超过7,000,000美元。我们现有的成人ACTG部门在招募非裔美国人和妇女方面排名全国，其中许多人都有滥用毒品的历史。数据管理被评为未偿还，主题保留是示范的。 CRS将从附属诊所招募，为30,000多名HIV感染和高危人士提供服务。这个新的CTU将汇集一大批有成就的调查人员，具有很强的协作历史，并将允许整合管理资源来进行监管事务，数据管理，外展和招聘。 在保留我们当前的HIV临床试验结构的成功方面，这种重组将通过提供集中的，共同的行政核心来使机构受益，这将允许约翰·霍普金斯（Johns Hopkins）以前无法实现的规模经济。最重要的是，从出生到青春期到成年和衰老，这三个组的结合将在整个年龄范围内提供预防和治疗研究的访问。该CTU的位置良好，可以继续为国家和国际艾滋病毒临床研究做出广泛而大量的贡献，同时还为其社区服务。 管理组件：