Pelvic Floor Disorders Network Data Coordinating Center: (2016-2021)

项目总结(见说明)： RTI建议继续担任NICHD盆底的数据协调中心(DCC) 疾病网络(PFDN)支持其改善对盆底疾病妇女的护理的使命 (PFDs)通过进行精心设计的多中心观察研究和临床试验为诊断提供信息， 预防和治疗。我们将在当前PFDN周期中作为DCC的工作基础上，提供 在研究设计和数据分析方面具有统计领导作用的网络，并通过数据提供操作支持 管理和后勤服务。具体地说，我们将(1)合作开发、实施和 监测网络协议；(2)提供数据管理，包括准备公共数据文件；(3) 为数据和安全监测委员会准备包括安全报告在内的报告；(4)在 数据分析和研究结果的公布；(5)协调研究药物和安慰剂的生产， 购置研究设备和材料，收集和运送生物标本； 提供所有其他支持，包括管理临床站点的收费和后勤 协调有效和富有成效的网络运行所需的会议和通信。 这一应用程序具有特定的优势，将提高人阵的科学生产力： (1)以玛丽·甘茨博士和丹尼斯·华莱士博士为首席调查员的DCC领导层的连续性 作为候补PI监督DCC团队，在PFD研究，包括盆腔器官研究方面经验丰富 脱垂、尿失禁和大便失禁。 (2)来自RTI和北卡罗来纳大学教堂山分校的生物统计学多学科专家， 统计遗传学、临床和生活质量结果、成本效益、计划评估和临床 PFD CARE，世卫组织将与人阵调查人员合作：(A)开发创新试验设计，包括 坐床到床边翻译研究；(B)制定新的成果措施，以填补目前的差距，特别是 患者认为至关重要的结果；以及(C)对网络分析需求的波动做出快速反应。 (3)最先进的数据收集系统，包括：(A)基于网络的临床电子数据捕获和 具有快速错误解决和实时报告及数据监测工具的管理系统；(B) 利用移动技术收集高质量的患者报告结果数据方面的进展；以及 (C)自动报告，每日跟踪研究登记和进展情况，以加强科学研究 临床现场试验活动的质量和效率。 相关性(请参阅说明)： PFDN成立于2001年，旨在通过精心设计的方案，改善对患有PFDs的妇女的护理 多中心观察性研究和临床试验，为诊断、预防和治疗提供信息。一个 合格、经验丰富的DCC在帮助人阵通过有效的 研究设计、实施、数据收集、质量保证、监测和统计分析。RTI将 继续提供多学科专业知识，支持高影响力的协作性临床研究 并提供通信和后勤支持，以优化网络的效率和生产力。

PROJECT SUMMARY (See instructions): RTI proposes to continue to serve as the data coordinating center (DCC) for the NICHD Pelvic Floor Disorders Network (PFDN) in support of its mission to improve the care of women with pelvic floor disorders (PFDs) by conducting well-designed multicenter observational studies and clinical trials to inform diagnosis, prevention, and treatment. We will build on our work as DCC in the current PFDN cycle to provide the Network with statistical leadership in study design and data analysis and operational support through data management and logistical services. Specifically, we will (1) collaborate in developing, implementing, and monitoring Network protocols; (2) provide data management, including preparation of public data files; (3) prepare reports including safety reports for the Data and Safety Monitoring Board; (4) collaborate in the analysis of data and publication of study results; (5) coordinate manufacturing of study drugs and placebos, acquisition of study equipment and materials, and collection and transport of biological specimens; and (6) provide all other support, including management of capitation payments to clinical sites, and logistical coordination of meetings and communications necessary to run an efficient and productive Network. This application has specific strengths that will enhance the scientific productivity of the PFDN: (1) Continuity of DCC leadership with Dr. Marie Gantz as Principal Investigator (PI) and Dr. Dennis Wallace as Alternate PI overseeing a DCC team experienced in PFD research, including studies of pelvic organ prolapse, urinary incontinence, and fecal incontinence. (2) Multidisciplinary experts, from RTI and The University of North Carolina, Chapel Hill, in biostatistics, statistical genetics, clinical and quality of life outcomes, cost-effectiveness, program evaluation, and clinical PFD care, who will collaborate with PFDN investigators to (a) develop innovative trial designs including bench-to-bedside translational studies; (b) develop new outcome measures to fill current gaps, particularly for outcomes patients consider crucial; and (c) respond quickly to fluctuations in Network analytic needs. (3) State-of-the-art data collection systems including (a) a web-based clinical electronic data capture and management system with rapid error resolution and real-time reports and data monitoring tools; (b) advancements in the collection of high-quality patient-reported outcome data using mobile technology; and (c) automated reports to provide daily tracking of study enrollment and progress to enhance the scientific quality and efficiency of clinical site trial activities. RELEVANCE (See instructions): The PFDN was established in 2001 to improve the care of women with PFDs by conducting well-designed multicenter observational studies and clinical trials to inform diagnosis, prevention, and treatment. A qualified, experienced DCC is critical in helping the PFDN optimize research productivity through effective study design, implementation, data collection, quality assurance, monitoring, and statistical analysis. RTI will continue to provide multidisciplinary expertise to support high-impact collaborative clinical research studies and provide communications and logistical support to optimize the efficiency and productivity of the Network.