BENIGN PROSTATIC HYPERPLASIA--A PILOT STUDY-DCC

乔治华盛顿大学生物统计中心建议 与NIDDK达成合作协议，担任数据协调 中心建议进行有限的多中心试验，以确定 不同的药物治疗模式在减少男性手术进展中的作用 患有良性前列腺增生症(BPH)。 九个月规划阶段的目标是制定一项议定书， 病例报告表、操作手册和数据处理系统 在有限的临床试验中实施。审判将需要 一年内至少100名BPH患者的招募和随机分组 在四个临床中心工作。符合条件的患者将被随机分配 要么服用安慰剂，要么服用三个治疗组之一(阿尔法-1 肾上腺素受体阻滞剂、5-α还原酶抑制剂，或两者兼而有之)。随机化 患者将接受平均6个月的随访(范围：2至12 月)。有限临床试验的结果将用于 通过以下方式确定进行全面临床试验的可行性 评估患者招募、患者对患者的耐受性和依从性 治疗方案，以及各种血清和尿动力学的有效性 测量作为疾病进展的标志。 良性前列腺增生症试点期间数据协调中心的具体目标 研究将提供集中的生物统计学支持和咨询 在设计领域(研究方案、病例报告表、业务 手动、随机化程序、分布式数据输入系统、质量 控制程序)、执行(数据处理支持、数据质量 评估、业绩监测、中期分析)，以及收尾、最终 分析和发布试点研究数据。

The Biostatistics Center of The George Washington University proposes to work in cooperative agreement with NIDDK to serve as the Data Coordinating Center for a proposed limited multicenter trial to determine the impact of different modes of drug treatment in reducing progression to surgery in men with benign prostatic hyperplasia (BPH). The objective of the nine month planning phase is to develop a protocol, case report forms, operations manual and data processing system to be implemented in a limited clinical trial. The trial will require the recruitment and randomization of at least 100 BPH patients over a one year period in four clinical centers. Eligible patients will be randomized either to a placebo or to one of three treatment groups (an alpha-1 adrenoceptor blocker, a 5-alpha reductase inhibitor, or both). Randomized patients will be followed for an average of 6 months (range: 2 to 12 months). The results of the limited clinical trial will be used to determine the feasibility of conducting a full-scale clinical trial by evaluation of patient recruitment, patient tolerance to and compliance with treatment regimens, and the usefulness of various serum and urodynamic measurements as markers of disease progression. The specific aims of the Data Coordination Center during the BPH pilot study are to provide centralized biostatistical support and consultation in the areas of design (study protocol, case report forms, operations manual, randomization procedures, distributed data entry system, quality control procedures), execution (data processing support, data quality assessment, performance monitoring, interim analysis), and close-out, final analysis, and publication of pilot study data.