Cornell Clinical Trials Unit

康奈尔临床试验单位

• 批准号: 7339333
• 负责人: ROY M. GULICK
• 金额: $ 118.44万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-01-10 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7339333
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Adherence; Adolescent; African American; Agreement; American; Anti-Retroviral Agents; Area; Asians; Clinical Investigator; Clinical Management; Clinical Research; Clinical Trials; Color; Communities; Community Outreach; Education and Outreach; HIV; HIV Infections; HIV Seroprevalence; Haiti; Hepatitis B; Hepatitis C; Heterosexuals; Human Papillomavirus; Immune; Infection; Injecting drug user; Latino; Leadership; Mentors; Morbidity - disease rate; Neighborhoods; Neurologic; New York City; Numbers; Outcome; Patients; Pharmaceutical Services; Play; Population; Positioning Attribute; Prevention; Protocols documentation; Rate; Research Personnel; Research Priority; Research Support; Risk; Role; Seroprevalences; Therapeutic Clinical Trial; Training; Translational Research; Vaccine Research; Vaccines; Vertical Disease Transmission; Woman; antiretroviral therapy; base; clinical research site; data management; drug development; experience; men who have sex with men; outreach; pregnancy prevention; research and development; therapeutic vaccine; young adult

DESCRIPTION (provided by applicant): An estimated 1 million Americans (and more than 90,000 New York City residents) have HIV infection. Despite recent advances, HIV/AIDS remains an important area for clinical investigation. This application describes the Cornell Clinical Trials Unit (CCTU), an HIV/AIDS therapeutic clinical trials unit that will affiliate with the 3 AIDS Clinical Trials Group (ACTG) network by prior agreement. The Cornell unit consists of an overall administrative core and two CRSs: Cornell Uptown and Cornell Chelsea. The core unit provides central research support to the CRSs including: investigative oversight, administration, study coordination, data management, regulatory, outreach, and pharmacy services. The two clinical research sites CRSs are located in different parts of New York City, in or close to the neighborhoods with the highest HIV seroprevalence rates: Cornell Uptown is located close to East Harlem (2.5% seroprevalence) and Cornell Chelsea is located in Chelsea-Clinton (4.1% seroprevalence). The two CRSs serve distinct patient populations that include significant numbers of women, people of color (African Americans, Asians, and Latinos), and adolescents/young adults from diverse risk groups (heterosexuals, injection drug users, men who have sex with men). With 17 years experience in the ACTG, the Cornell unit has broad scientific and clinical research experience in diverse areas including: antiretroviral agents and strategies; complications of HIV and antiretroviral therapies; immune-based therapies, including vaccines; co-infections (e.g. hepatitis B, hepatitis C, and human papillomavirus); neurological complications; adherence and outcomes; HIV-infected women and pregnancy; and prevention of mother-to-child transmission of HIV. The Cornell unit will contribute to the priority research areas of the ACTG: translational research/drug development; optimization of clinical management, including co-morbidities; therapeutic vaccine research and development; and prevention of mother-to-child transmission. Cornell investigators serve in ACTG leadership positions, on ACTG committees, and ACTG protocol teams (including protocol leadership for 11 current studies). Cornell has strong ties to Haiti and plays an active role in mentoring and training Haitian HIV/AIDS clinical investigators. A major focus of the Cornell unit is community outreach and education and the Cornell Community Advisory Board is active in representing our diverse community. ADMINISTRATIVE COMPONENT:

描述（由申请人提供）：估计有100万美国人（和90,000多名纽约市居民）患有艾滋病毒感染。尽管最近进展，艾滋病毒/艾滋病仍然是临床研究的重要领域。该申请描述了康奈尔临床试验单元（CCTU），这是一个艾滋病毒/艾滋病治疗临床试验单元，该试验将通过事先协议与3个艾滋病临床试验组（ACTG）网络相关。康奈尔（Cornell）单位由一个整体行政核心和两个CRS组成：康奈尔（Cornell）上城区和康奈尔·切尔西（Cornell Chelsea）。核心部门为CRS提供了中央研究支持，包括：调查监督，管理，研究协调，数据管理，监管，外展和药房服务。 CRS的两个临床研究地点位于纽约市的不同地区，靠近HIV HIV率率最高的社区：Cornell Eusttown靠近东哈林（2.5％的血清阳性），Cornell Chelsea位于Chelsea-Clinton（4.1％的血清降低）。这两个CRS服务于不同的患者人群，其中包括大量女性，有色人种（非裔美国人，亚洲人和拉丁裔）以及来自不同风险群体的青少年/年轻人（异性恋，注射吸毒者，与男性发生性关系的男性）。 Cornell部门拥有17年的ACTG经验，在不同领域具有广泛的科学和临床研究经验，包括：抗逆转录病毒药物和策略；艾滋病毒和抗逆转录病毒疗法的并发症；基于免疫的疗法，包括疫苗；共感染（例如乙型肝炎，乙型肝炎和人乳头瘤病毒）；神经系统并发症；依从性和结果；艾滋病毒感染的妇女和怀孕；并预防艾滋病毒的母子传播。康奈尔单位将有助于ACTG的优先研究领域：转化研究/药物开发；临床管理的优化，包括合并症；治疗疫苗的研究与开发；和预防母子传播。康奈尔调查人员在ACTG领导职务，ACTG委员会和ACTG协议团队（包括11项目前研究的协议领导力）中任职。康奈尔（Cornell）与海地有着密切的联系，并在指导和训练海地艾滋病毒/艾滋病临床研究者中发挥了积极作用。康奈尔部门的主要重点是社区宣传和教育，康奈尔社区顾问委员会积极代表我们的多元化社区。 管理组件：