OPERATIONS CENTER FOR AIDS-ASSOCIATED MALIGNANCIES

艾滋病相关恶性肿瘤手术中心

• 批准号: 2458233
• 负责人: Jeannette Y. Lee
• 金额: $ 97.09万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-30 至 1999-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2458233
• 关键词: AIDS; AIDS related neoplasm /cancer; AIDS therapy; Hodgkin's disease; Kaposi's sarcoma; cancer information system; clinical trials; cooperative study; data collection; dosage; human subject; human therapy evaluation; neoplasm /cancer therapy; nonHodgkin's lymphoma; statistics /biometry

DESCRIPTION: (Applicant's Description) This proposal is for the Comprehensive Cancer Center Biostatistics Unit at the University of Alabama at Birmingham (UAB) to serve as the Operations, Statistical and Data Management Center (OMC) for the AIDS-Associated Malignancies Clinical Trials Consortium. The purpose of the Consortium is to design and conduct clinical trials with novel agents or innovative approaches in patients with AIDS-associated malignancies, primarily Non-Hodgkin's Lymphoma (NHL), Kaposi's sarcoma (KS), Hodgkin's disease, anogenital dysplasia, anal and cervical cancer. It is anticipated that the Consortium will perform four to six clinical trials and enroll 200 patients per year with AIDS-associated malignancies from 8 to 10 clinical centers. The OMC will centralize many activities of the clinical trials, and will serve as the communications hub for the Consortium. The OMC will provide statistical expertise to the Consortium in the areas of study design, sample size, and analyses; coordinate the development, submission, conduct and analysis of protocols undertaken by the Consortium; establish and implement quality control procedures; monitor the conduct of the clinical trials; establish and implement procedures for data management; maintain the database for the clinical trials; perform all statistical analyses; manage the Discretionary Fund; coordinate the acquisition and shipping of specimens and relevant clinical data to the Tissue and Biological Fluids Banks of HIV- Associated Malignancies; and provide administrative support for the study. The Biostatistics Unit has considerable experience in serving as the statistical coordinating center for multicenter clinical trials groups. The location of all personnel involved in coordinating center activities in one physical location is both cost and time efficient. With both an NIH-funded Comprehensive Cancer Center and Center for AIDS Research at UAB, expertise in the medical, virologic, oncologic, immunologic, epidemiologic, and behavioral areas will be available to the OMC on an ongoing basis.

描述：（申请人的描述）此提案是针对的 大学综合癌症中心生物统计学部门 伯明翰（UAB）的阿拉巴马州作为运营，统计和 数据管理中心（OMC）用于艾滋病相关的恶性肿瘤 临床试验财团。财团的目的是设计 并使用新颖的代理或创新方法进行临床试验 在患有艾滋病相关的恶性肿瘤的患者中，主要是非霍奇金 淋巴瘤（NHL），卡波西肉瘤（KS），霍奇金氏病，肛门生殖器 发育不良，肛门和宫颈癌。预计 财团将进行四到六项临床试验，并注册200 每年患有艾滋病相关的恶性肿瘤的患者从8到10个临床 中心。 OMC将集中临床试验的许多活动，并将 充当财团的通信枢纽。 OMC会 在研究领域为财团提供统计专业知识 设计，样本量和分析；协调发展， 提交，进行和分析协议 财团；建立和实施质量控制程序；监视器 临床试验的行为；建立和实施程序 用于数据管理；维护临床试验的数据库； 执行所有统计分析；管理酌处基金； 协调标本和相关标本的收购和运输 HIV-的组织和生物流体库的临床数据 相关的恶性肿瘤；并为 学习。 生物统计学部门在担任的经验丰富 多中心临床试验组的统计协调中心。 所有参与协调中心活动的人员的位置 在一个物理位置，既有成本又是时间效率。两者都 NIH资助的综合癌症中心和艾滋病研究中心 UAB，医学，病毒，肿瘤学，免疫学的专业知识， 流行病学和行为领域将在OMC上使用 持续的基础。