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.
