Data Coordinating Center for Benign Prostate Symptoms

描述（由申请人提供）： 该提案是由伯明翰亚拉巴马大学医学统计科（MSS）作为良性前列腺症状替代疗法研究的数据协调中心（DCC）。预计10个临床评价和治疗中心（CETC）将招募约3100名患有良性前列腺增生（BPH）的男性参与一项随机、双盲、安慰剂对照研究，研究两种植物治疗药物Serenoa repens（锯棕榈）和Pygeum africanum治疗BPH。DCC的具体目标是：为研究设计和分析提供统计专业知识;为研究提供数据管理支持;开发和维护一个基于Web的系统，用于CETC向DCC的数据传输和通信;建立一个植物疗法分发中心，向CETC分发锯棕榈、非洲臀果木和安慰剂;并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的优势在于：其完善的基础设施（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;其作为NIH支持的多中心临床试验组的协调中心的经验;以及其在UAB化学预防中心的参与。

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.