St. Jude/Memphis IMPAACT Clinical Trials Unit (Composite)

圣裘德/孟菲斯 IMPAACT 临床试验单位（综合）

• 批准号: 7559639
• 负责人: PATRICIA MICHELE FLYNN
• 金额: $ 75.01万
• 依托单位: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7559639
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Accounting; Acquired Immunodeficiency Syndrome; Address; Adolescent; Affect; African American; Age; Agreement; Area; Arkansas; Centers for Disease Control and Prevention (U.S.); Child; Childhood; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Unit; Conduct Clinical Trials; Country; Data; Epidemic; Epidemiology; Growth; HIV; HIV Infections; Health Sciences; Healthcare; Individual; International; International Unit; Location; Minority Groups; Mississippi; Missouri; Morbidity - disease rate; National Institute of Allergy and Infectious Disease; Patients; Population; Prevention; Radial; Recording of previous events; Reporting; Saint Jude Children' s Research Hospital; Site; Tennessee; Translational Research; Universities; Vaccine Research; Woman; base; drug development; experience; improved; pediatric AIDS; research and development; transmission process; urban area

DESCRIPTION (provided by applicant): Clinical research, much of it sponsored by NIAID, has markedly improved survival of patients with HIV/AIDS. However, the epidemic continues to grow both in both developed and the developing world. In the U.S., minority groups, especially African-Americans, are disproportionately affected throughout the country. Nationally, African-Americans make up 40% of AIDS cases but only 12.3% of the U.S. population. This disparity is even greater among children and adolescents (ages 13 to 19 years), among whom African Americans make up 60% of AIDS cases but only 15% of the U.S. population. In Memphis, approximately 46% of the population is African-Americans but 90% of the HIV and AIDS cases occur n African-Americans. In addition, data from the CDC show that cumulatively, 36% of all reported AIDS cases have been in the South, but the South accounted for 45% of new AIDS cases in 2003. These data confirm the disproportionate growth of the epidemic in this region. Because of the evolving epidemiology of HIV infection in the U.S., Memphis is an ideal location for a domestic HIV/AIDS Clinical Trial Unit (CTU). Memphis is a large Southern urban area that provides tertiary health care for individuals in an approximately 200-mile radius in the states of Tennessee, Mississippi, Missouri, and Arkansas. This area has been identified as one of the poorest in the nation. Here, the proposed CTU, located at: St. Jude Children's Research Hospital, will provide clinical trial access for to underrepresented populations that are most severely affected by the epidemic;, including women, adolescents, and African-Americans. The proposed CTU is currently a Pediatric AIDS Clinical Trials Group Unit and is affiliated with the International Maternal Pediatric Adolescent Clinical Trials (IMPAACT) Group. The unit will have a single site located at St. Jude with a consortium agreement with the University of Tennessee Health Science Center. The unit will address all four scientific aims of IMPAACT: Prevention of Maternal to Child Transmission of HIV; Translational Research/Drug Development; Optimization of Clinical Management including Co- Morbidities; and Vaccine Research and Development. Based on the availability of severely affected populations, the experienced staff, and the strong history of clinical trial conduct and scientific contributions to the PACTG, the St Jude CTU will be a valued domestic unit for IMPAACT. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：临床研究（由NIAID赞助）显着改善了HIV/AIDS患者的生存率。但是，在发达国家和发展中国家中，流行病都在不断增长。在美国，少数群体，尤其是非裔美国人，在全国范围内受到不成比例的影响。在全国范围内，非裔美国人占艾滋病案件的40％，但仅占美国人口的12.3％。在儿童和青少年中，这种差异甚至更大（13至19岁），其中非裔美国人占艾滋病案件的60％，但仅占美国人口的15％。在孟菲斯，大约46％的人口是非裔美国人，但90％的艾滋病毒和艾滋病案件发生了非裔美国人。此外，来自CDC的数据表明，累计，所有报告的艾滋病病例中有36％在南部，但南方在2003年占新艾滋病病例的45％。这些数据证实了该地区流行病的不成比例增长。由于美国艾滋病毒感染的流行病学不断发展，孟菲斯是国内艾滋病毒/艾滋病临床试验单元（CTU）的理想场所。孟菲斯是一个大型南部城市地区，在田纳西州，密西西比州，密苏里州和阿肯色州的州大约200英里半径的个人为三级卫生保健提供。该地区已被确定为美国最贫穷的地区之一。在这里，拟议的CTU位于以下位置：圣裘德儿童研究医院，将为人口不足的人群提供临床试验，这些人群受到该流行病的影响最严重；包括妇女，青少年和非裔美国人在内。拟议的CTU目前是儿科AIDS临床试验组单元，隶属于国际母亲小儿青少年临床试验（Inmbaact）组。该部门将与田纳西大学健康科学中心达成一项财团协议，在圣裘德有一个地点。该部门将解决所有四个科学目标：预防母亲到艾滋病毒的儿童传播；翻译研究/药物开发；临床管理的优化，包括病毒；和疫苗研发。根据受到严重影响的人群的可用性，经验丰富的员工以及临床试验行为的悠久历史和对帕克族的科学贡献的历史，St Jude CTU将成为不可思议的国内贵族单位。 管理组件：