MEDICAL THERAPY AND BPH

本建议书提供了有关临床的详细信息和计划 北京协和医院泌尿外科和预防医学部试验中心 爱荷华大学的良性医学治疗的全面试验 前列腺增生症。这个临床试验中心的规划已经 为确保该中心成功地满足长期 多中心试验的目标。具体地说，这项提案提供了 详细信息，以确定我们实现招聘目标的能力 包括少数群体，确保参与者的资格， 准确高效地执行协议跟踪，及时执行数据 录入和完成，有效地与数据进行沟通协调 中心和诊断中心，并保持患者的兴趣和 合规性。 为了确保临床中心有能力满足上述要求 具体目标，已经组织了一个多学科的研究小组 这场审判。这个团队的成员是根据广泛的 以前的临床研究经验，诊断方面的专业知识， 男性排尿功能障碍的管理和治疗 在大规模临床试验中招募病人的技能。这个核心 研究小组与更多的研究人员合作，一直在 以高效的管理结构组织起来，旨在满足 高于特定的目标。通过这个结构，完善和精致 针对所需患者群体的营销策略将是 为达到工作量目标而实施。在以下地区的两个卫星诊所 更高密度的少数民族人口将增强我们招募新兵的能力 这些患者以及扩大我们通过其覆盖范围 可能会访问参与者。故障保护机制概述如下 旨在确保我们有能力实现应计目标，准确和 高效跟踪，及时录入数据，提供高质量 信息发送到数据协调中心。此外，我们还概述了 我们在整个漫长的治疗过程中保持患者依从性的策略 这项试验的后续进程。 综上所述，这项建议审查了这两个临床 审判中心，以及该中心将以何种具体方式 在良性前列腺增生症药物治疗试验中的作用。

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.