Cornell Clinical Trials Unit

康奈尔临床试验单位

基本信息

批准号：
8139499
负责人：
ROY M. GULICK
金额：
$ 18.07万
依托单位：
WEILL MEDICAL COLL OF CORNELL UNIV
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-27 至 2011-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8139499
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 Clinical Trials Unit Color Communities Community Outreach Comorbidity Education HIV HIV Infections HIV Seroprevalence Haiti Hepatitis B Hepatitis C Heterosexuals Human Papillomavirus Immune Infection Injecting drug user Latino Leadership Mentors Neighborhoods Neurologic New York City Outcome Pharmaceutical Services Play Positioning Attribute Prevention Protocols documentation 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 patient population pregnancy prevention research and development therapeutic vaccine young adult

项目摘要

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（以及超过 90,000 名纽约市居民）感染 HIV。尽管最近取得了进展，艾滋病毒/艾滋病仍然是临床研究的一个重要领域。本申请描述了康奈尔大学临床试验单位 (CCTU)，这是一个 HIV/艾滋病治疗临床试验单位，根据事先协议，该单位将隶属于 3 艾滋病临床试验组 (ACTG) 网络。康奈尔单位由一个整体行政核心和两个 CRS 组成：康奈尔住宅区和康奈尔切尔西。核心单位为 CRS 提供中央研究支持，包括：调查监督、管理、研究协调、数据管理、监管、外展和药学服务。这两个临床研究地点 CRS 位于纽约市的不同地区，位于或靠近 HIV 血清阳性率最高的社区：康奈尔住宅区位于东哈莱姆区附近（血清阳性率为 2.5%），康奈尔切尔西位于切尔西 -克林顿（4.1% 血清阳性率）。这两个 CRS 服务于不同的患者群体，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、男男性行为者）。康奈尔大学单位在 ACTG 拥有 17 年的经验，在不同领域拥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； HIV和抗逆转录病毒治疗的并发症；基于免疫的疗法，包括疫苗；合并感染（例如乙型肝炎、丙型肝炎和人乳头瘤病毒）；神经系统并发症；坚持和结果；感染艾滋病毒的妇女和怀孕；和预防艾滋病毒母婴传播。康奈尔大学单位将为 ACTG 的优先研究领域做出贡献：转化研究/药物开发；优化临床管理，包括合并症；治疗性疫苗的研究和开发；和预防母婴传播。康奈尔大学的研究人员担任 ACTG 领导职务、ACTG 委员会和 ACTG 方案团队（包括 11 项当前研究的方案领导）。康奈尔大学与海地有着密切的联系，并在指导和培训海地艾滋病毒/艾滋病临床研究人员方面发挥着积极作用。康奈尔大学部门的一个主要重点是社区外展和教育，康奈尔大学社区咨询委员会积极代表我们多元化的社区。行政部分：