MEDICAL THERAPY AND BPH

药物治疗和良性前列腺增生

• 批准号: 2900305
• 负责人: WILLIAM A SEE
• 金额: $ 32.98万
• 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/2900305
• 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.

该提案提供了有关临床研究的详细信息和计划， 泌尿科和预防医学系的试验中心， 爱荷华州大学的良性肿瘤药物治疗的全面试验 前列腺增生该临床试验中心的规划 为确保中心成功实现长期目标而进行的 多中心试验的目的。具体而言，该提案规定， 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， 进行准确、高效的方案随访，及时提供数据 录入和完成，与数据协调有效沟通 中心和诊断中心，并保持患者的兴趣， 合规 为确保临床中心满足上述要求的能力 为了实现具体目标，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 有临床研究经验，诊断专业知识， 男性排尿功能障碍的管理和治疗， 为大规模临床试验招募患者的技能。这一核心 研究团队与其他研究人员合作， 组织在一个有效的行政结构，旨在满足 高于具体目标。通过这种结构，完善和完善 针对所需患者人群的营销策略将 以实现工作应计目标。在下列地区设立两个卫星诊所： 更高密度的少数民族人口将提高我们招募的能力， 这些病人，以及扩大集水区，通过我们 可以访问参与者。故障安全机制概述如下 旨在确保我们有能力实现应计目标， 有效的后续行动，及时输入数据，并提供高质量的 向数据协调中心提供信息。此外，我们还概述了 我们的策略，以维持病人的依从性，在整个长期 本试验的后续过程。 总之，本提案审查了本临床试验机构的资格， 试验中心，以及该中心将 为良性前列腺增生的药物治疗试验提供了依据。