MEDICAL THERAPY AND BPH

药物治疗和良性前列腺增生

• 批准号: 2150934
• 负责人: WILLIAM A SEE
• 金额: $ 33.12万
• 依托单位: UNIVERSITY OF IOWA
• 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/2150934
• 关键词: alpha antiadrenergic agent; benign prostate hyperplasia; clinical trials; cooperative study; enzyme inhibitors; human subject; human therapy evaluation; male; reproductive system disorder chemotherapy

This proposal provides detailed information on, and plans for, a clinical trial center in the Departments of Urology and Preventive Medicine at the University of Iowa for the full-scale trial of medical therapy in benign prostatic hyperplasia . The planning for this clinical trial center has been performed to ensure the center's success in meeting the long-term objectives of the multicenter trial. Specifically, this proposal provides detailed information to establish our ability to meet recruitment goals including minority populations, ensure eligibility of participants, perform accurate and efficient protocol follow-up, perform timely data entry and completion, effectively communicate with the data coordinating center and diagnostic center, and maintain patient interest and compliance. In order to ensure the ability of the clinical center to meet the above specific aims, a multi-disciplinary research team has been organized for this trial. Members of this team have been recruited based upon extensive prior experience in clinical research, expertise in the diagnosis, management and treatment of male voiding dysfunction, and well-established skills in patient recruitment for large-scale clinical trials. This core research team, in concert with additional study personnel, has been organized in an efficient administrative structure intended to meet the above specific aims. Through this structure, well-established and refined marketing strategies targeted at the desired patient population will be implemented to meet work accrual goals. Two satellite clinics in areas of higher density minority populations will enhance our ability to recruit these patients as well as broaden the catchment area through which we might access participants. Fail-safe mechanisms are outlined which are intended to ensure our ability to meet accrual goals, perform accurate and efficient follow-up, enter data in a timely fashion, and provide quality information to the data coordinating center. In addition, we have outlined our strategy for maintaining patient compliance throughout the protracted follow-up course of this trial. In summary, this proposal reviews both the qualifications of this clinical trial center, as well as the specific manner in which this center will function for the trial of medical therapy in benign prostatic hyperplasia.

该提案提供了临床试验的详细信息和计划 泌尿外科和预防医学系试验中心 爱荷华大学对良性肿瘤进行全面的药物治疗试验 前列腺增生 。该临床试验中心的规划 已执行，以确保中心成功满足长期目标 多中心试验的目标。具体来说，该提案规定 确定我们实现招聘目标的能力的详细信息 包括少数民族人口，确保参与者的资格， 执行准确高效的方案跟进，执行及时的数据 录入与完成，与数据有效沟通协调 中心和诊断中心，并维护患者的兴趣和 遵守。 为了保证临床中心满足上述的能力 为实现特定目标，组织了一个多学科研究小组 这次审判。该团队的成员是根据广泛的 先前的临床研究经验、诊断专业知识、 男性排尿功能障碍的管理和治疗，并已确立 大规模临床试验患者招募的技能。这个核心 研究小组与其他研究人员合作， 以高效的行政结构组织起来，旨在满足 以上具体目标。通过这种结构，完善和完善 针对所需患者群体的营销策略将是 实施以实现工作应计目标。两个卫星诊所分布在以下地区 较高密度的少数族裔人口将增强我们的招募能力 这些患者以及扩大我们的服务范围 可能会访问参与者。概述了故障安全机制，其中包括 旨在确保我们有能力实现应计目标、执行准确和 高效跟进，及时录入数据，提供优质 信息发送至数据协调中心。此外，我们还概述了 我们在整个长期过程中保持患者依从性的策略 本次试验的后续过程。 总之，该提案审查了该临床的资格 审判中心，以及该中心将采取的具体方式 试验良性前列腺增生药物治疗的功能。