Data Coordinating Center for Benign Prostate Symptoms

良性前列腺症状数据协调中心

• 批准号: 6668571
• 负责人: Jeannette Y. Lee
• 金额: $ 78.09万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6668571
• 关键词: alternative medicine; benign prostate hyperplasia; chemotherapy; clinical research; computer network; data management; human data; human therapy evaluation; information systems; plant extracts; statistics /biometry; telecommunications

DESCRIPTION (provided by applicant): This proposal is for the Medical Statistics Section (MSS) at the University of Alabama at Birmingham to serve as the Data Coordinating Center (DCC) for the study of alternative therapies in benign prostate symptoms. It is anticipated that 10 Clinical Evaluation and Treatment Centers (CETCs) will enroll approximately 3100 men with benign prostatic hyperplasia (BPH) in a randomized, double-masked, placebo-controlled study of two phytotherapy agents, Serenoa repens (Saw palmetto) and Pygeum africanum in the treatment of BPH. Specific aims of the DCC are to: provide statistical expertise in study design and analyses; provide data management support for the study; develop and maintain a WEB-based system for data transmission and communication from the CETCs to the DCC; establish a Phytotherapy Distribution Center to distribute Saw palmetto, Pygeum africanum and placebo to the CETCs; and provide administrative support for meetings of the Steering and Planning Committee, Executive Committee, Data Safety and Monitoring Board and any subcommittees formed during the progress of the trial. The strengths of the MSS in serving as the DCC are: its well-established infrastructure (personnel, computing facilities, communications networks, and data management system) for providing support to clinical trials; its experience in serving as the coordinating center for NIH-supported multicenter clinical trials groups; and its participation in the UAB Chemoprevention Center.

描述（由申请人提供）： 该建议是针对伯明翰阿拉巴马大学的医学统计部分（MSS）作为数据协调中心（DCC）的研究，用于研究良性前列腺症状中的替代疗法。预计10个临床评估和治疗中心（CETC）将在一项随机的，双掩盖的，安慰剂对照的研究中，大约有3100名患有良性前列腺增生（BPH）的男性，对两种植物治疗剂，Serenoa Repens（Serenoa Repens（Saw Palmetto）和Pygeum Africanum进行了BPH的治疗。 DCC的具体目标是：提供研究设计和分析方面的统计专业知识；为研究提供数据管理支持；开发并维护一个基于Web的系统，用于从CETC到DCC的数据传输和通信；建立一个植物疗法分配中心，将锯棕榈，非洲人和安慰剂分发到CETC；并为指导和计划委员会，执行委员会，数据安全和监测委员会以及审判进度期间成立的任何小组委员会的会议提供行政支持。 MSS作为DCC的优势是：其良好的基础设施（人员，计算设施，通信网络和数据管理系统）为临床试验提供支持；它在担任NIH支持的多中心临床试验小组协调中心方面的经验；及其参与UAB化学预防中心。