OPERATIONS CENTER FOR AIDS-ASSOCIATED MALIGNANCIES

描述：(申请人描述)本建议书适用于 加州大学综合癌症中心生物统计部 阿拉巴马州伯明翰分校(UAB)担任运营、统计和 艾滋病相关恶性肿瘤数据管理中心(OMC) 临床试验协会。该联盟的目的是设计 并使用新药或创新方法进行临床试验 艾滋病相关恶性肿瘤患者，主要是非何杰金氏病 淋巴瘤(NHL)、卡波西肉瘤(KS)、何杰金氏病、肛门生殖器 不典型增生、肛门癌和宫颈癌。据预计， 财团将进行4至6项临床试验，并招募200人 每年8至10个临床艾滋病相关恶性肿瘤患者 中锋。 OMC将集中临床试验的许多活动，并将 作为财团的通信枢纽。OMC将 在研究领域向财团提供统计专业知识 设计、样本大小和分析；协调开发； 提交、执行和分析由 建立和实施质量控制程序；监督 临床试验的进行；建立和实施程序 用于数据管理；维护临床试验数据库； 执行所有统计分析；管理可自由支配基金； 协调标本和相关材料的获取和运输 HIV组织和生物体液库的临床数据- 和提供行政支持。 学习。 生物统计股在担任 多中心临床试验小组统计协调中心。 协调中心活动的所有人员的所在地 在一个物理位置既节省成本又节省时间。同时具有一个 美国国立卫生研究院资助的综合性癌症中心和艾滋病研究中心 UAB，医学、病毒学、肿瘤学、免疫学、 流行病学和行为学领域将向OMC提供 持续的基础上。

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.