MEDICAL THERAPY IN BPH--FULL SCALE TRIAL

BPH 的药物治疗——全面试验

• 批准号: 2698229
• 负责人: AARON K KIRKEMO
• 金额: $ 0.5万
• 依托单位: HENRY FORD HEALTH SYSTEM
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-04-27 至 2002-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2698229
• 关键词: MEDICAL; THERAPY; BPH; FULL; SCALE

This proposal outlines our plan as a Clinical Center to implement the protocol developed by the Benign Prostatic Hyperplasia (BPH) steering committee for the clinical trial of medical therapy in BPH. The protocol is designed to evaluate men with moderate and severe symptoms of prostatism, randomized into one of 4 study arms consisting of doxazosin, finasteride, doxazosin and finasteride, and placebo. Specifically, we detail how we will coordinate efforts to recruit, evaluate, treat and follow up at least 200 patients in the time frame required. The investigators have extensive experience and expertise not only in the clinical and epidemiological aspects of BPH, but also in the design, conduct and implementation of collaborative clinical trials on the pharmacologic treatment of BPH. Over the pst three years, the HFHS/William Beaumont group has demonstrated the ability to successfully collaborate in an ongoing multicenter NIH U01 cooperative study. An objective of this study is to collaborate fully with other Clinical Centers. All the required data will be sent to the Data Coordinating Center and the appropriate specimens will be sent to the Diagnostic Center for proper processing. Another objective of this study is the timely recruitment of eligible patients including a representative number of minority patients. The Henry Ford/Beaumont Centers draw from a large population with unique demographics including an established relationship with a large minority population. In our ongoing NIH collaborative study we are leading in minority recruitment. In concert with public relations an intensive marketing plan has been developed. Additionally, we have established a relationship with local industry to promote accrual and to provide unique economic data on the direct and indirect costs of BPH treatment. The Henry Ford/Beaumont Center has the appropriate environment and physical facilities to perform as a clinical center. The clinical and laboratory space, ultrasound for prostate and post void residual, and complex urodynamic equipment are available. Significance experience with computers and appropriate data bases on an established system wide IBM compatible network will ensure consistent data collection throughout enrollment, intervention and follow up from the peripheral satellite facilities.

这份建议书概述了我们作为临床中心实施 良性前列腺增生症(BPH)指导制定的方案 良性前列腺增生症药物治疗临床试验委员会。该协议 旨在评估有中度和严重的 前列腺素，随机分成由多沙唑嗪组成的4个研究组之一， 非那雄胺，多沙唑嗪和非那雄胺，以及安慰剂。具体来说，我们 详细说明我们将如何协调努力，以招聘、评估、治疗和 在要求的时间范围内对至少200名患者进行跟踪调查。 调查人员拥有丰富的经验和专业知识，不仅在 BPH的临床和流行病学方面，但也在设计中， 开展和实施联合临床试验 前列腺增生症的药物治疗。在太平洋标准时间的三年里， HFHS/William Beaumont集团已证明有能力成功 参与正在进行的多中心NIH U01合作研究。一个 本研究的目标是与其他临床医生充分合作 中锋。所有需要的数据都将发送到数据协调中心 中心，适当的样本将被送到诊断中心 以便进行适当的处理。 这项研究的另一个目标是及时招聘合格的 患者包括具有代表性的少数族裔患者。这个 亨利·福特/博蒙特中心从庞大的人口中吸引了独特的 人口统计数据，包括与一大批少数人建立的关系 人口。在我们正在进行的NIH合作研究中，我们领先于 少数族裔招募。与公共关系协调一致的密集的 已经制定了营销计划。此外，我们还建立了一个 与当地行业的关系，以促进应计利润并提供独特的 关于前列腺增生症治疗的直接和间接成本的经济数据。 亨利·福特/博蒙特中心拥有合适的环境和 作为临床中心发挥作用的物理设施。临床和临床 实验室空间，前列腺和尿管残留的超声检查，以及 可提供复杂的尿流动力学设备。重要的体验： 在已建立的全系统IBM上建立计算机和适当的数据库 兼容的网络将确保在整个过程中收集一致的数据 从外围卫星进行登记、干预和跟踪 设施。