Data Coordinating Center for Benign Prostate Symptoms

描述(由申请人提供)： 这项建议是为了让阿拉巴马大学伯明翰分校的医学统计科(MSS)作为研究良性前列腺症状替代疗法的数据协调中心(DCC)。预计10个临床评估和治疗中心(CETC)将招募大约3100名患有良性前列腺增生症(BPH)的男性患者参加一项随机、双掩蔽、安慰剂对照的研究，研究两种植物治疗药物--Serenoa epens(锯棕榈)和Pygeum African anum治疗BPH。DCC的具体目标是：在研究设计和分析方面提供统计专业知识；为研究提供数据管理支持；开发和维护一个网络系统，用于CETC和DCC之间的数据传输和通信；建立植物疗法分配中心，向CETC分发锯棕榈、非洲腐乳和安慰剂；为指导和规划委员会、执行委员会、数据安全和监测委员会以及试验进展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：为临床试验提供支持的完善的基础设施(人员、计算设施、通信网络和数据管理系统)；作为NIH支持的多中心临床试验小组的协调中心的经验；以及参与UAB化学预防中心。

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.