AIDS CLINICAL TRIALS

艾滋病临床试验

• 批准号: 2063177
• 负责人: HENRY W. MURRAY
• 金额: $ 144.79万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 1987
• 资助国家: 美国
• 起止时间: 1987-09-30 至 1995-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2063177
• 关键词: AIDS; AIDS therapy; HIV infections; clinical trials; cooperative study; human subject; human therapy evaluation

For the 1991 ACTG recompetition, the independent ACTUs at Cornell University Medica College (CUMC) and Memorial Sloan-Kettering Cancer Center (MSKCC) have elected to merge as one Main ACTU and add two new Subunits, St. Clare's Hospital in Manhattan and North Shore University Hospital on Long Island. MSKCC is also applying for Virology and Pharmacology Core Laboratories. The merger of the CUMC and MSKCC ACTUs will provide the key opportunities to (a) streamline and consolidate shared ACTU activities, (b) increase cost efficiency while maintaining enrollment, and (c) rationally focus and direct high priority trials at one site which has either recognized clinical expertise or an optimal dedicated clinical facility. The addition of St. Clare's (the most active HIV Unit on the East Coast) and North Shore as Subunits will enhance accrual of women, minorities, IVDUs, and prisoners, extend the ACTG network to underserved areas of New York City (Queens) and Long Island, and provide the ACTG with additional investigators expert in HIV-related disease. The CUMC and MSKCC ACTUs have made clear scientific contributions to the ACTG, and have demonstrated high-level accomplishments in phase I, II, and III protocols in three ACTG priority areas: Primary HIV Infection, Opportunistic Infections (OI), and Oncology in OI trials enrollment, CUMC- MSKCC together ranks first in New York City and seventh nationally, and in Oncology trials enrollment ranks first in New York City and second nationally. Maintaining this high level of participation in OI and Oncology studies will be the primary objective of the new CUMC-MSKCC ACTU and its Subunits. In addition to the large endogenous patient populations already at the Main CUMC-MSKCC ACTU sites and the two Subunits (both are New York State Designated AIDS Care Units), more than 40 separate linkages will also be used as sources of trials patients with clear emphasis on recruitment of under-represented groups. Other particularly important components of the new CUMC-MSKCC ACTU include a new large (dedicated) outpatient unit, a supportive GCRC, investigators skilled in OI and Oncology trials, an active Community Advisory Board, and nursing, administrative, data management, and pharmacy staffs thoroughly experienced in ACTG clinical trials work. Together, CUMC-MSKCC with its Subunits provides a unique ACTU for conducting high priority ACTG studies.

对于 1991 年 ACTG 复赛，康奈尔大学的独立 ACTU 大学医学院 (CUMC) 和纪念斯隆-凯特琳癌症中心 (MSKCC) 已选择合并为一个主要 ACTU 并添加两个新的子单位， 曼哈顿圣克莱尔医院和北岸大学医院 长岛。 MSKCC 也在申请病毒学和药理学核心 实验室。 CUMC 和 MSKCC ACTU 的合并将提供关键 (a) 简化和巩固共同的 ACTU 活动的机会，(b) 在保持入学率的同时提高成本效率，以及 (c) 合理地 将重点放在一个地点并直接进行高优先级试验，该地点具有以下任一条件： 公认的临床专业知识或最佳的专用临床设施。 增加圣克莱尔医院（东海岸最活跃的艾滋病毒部门） 和北岸作为子单位将提高妇女、少数族裔、 IVDU 和囚犯将 ACTG 网络扩展到新州服务欠缺的地区 约克市（皇后区）和长岛，并向 ACTG 提供额外的 研究人员是艾滋病毒相关疾病的专家。 CUMC 和 MSKCC ACTU 为该领域做出了明确的科学贡献 ACTG，并在 I、II 期和 三个 ACTG 优先领域的 III 方案：原发性 HIV 感染、 机会性感染 (OI) 和 OI 试验招募中的肿瘤学，CUMC- MSKCC 在纽约市排名第一，在全国排名第七， 肿瘤学试验注册人数在纽约市排名第一、第二 全国范围内。 保持 OI 的高水平参与 肿瘤学研究将是新的 CUMC-MSKCC ACTU 的主要目标 及其亚基。 除了大量的内源性患者群体 已经在 CUMC-MSKCC ACTU 主站点和两个子单位（均是 纽约州指定艾滋病护理单位），超过 40 个独立的联系 也将被用作试验的来源，明确强调 招募代表性不足的群体。 其他特别重要的 新 CUMC-MSKCC ACTU 的组件包括一个新的大型（专用） 门诊部、支持性 GCRC、擅长 OI 的研究人员和 肿瘤学试验、活跃的社区咨询委员会和护理， 行政、数据管理和药学人员经验丰富 从事ACTG临床试验工作。 CUMC-MSKCC 及其子单位一起 为进行高优先级 ACTG 研究提供了独特的 ACTU。