Pelvic Floor Disorders Network Data Coordinating Center (U01)

描述(由申请人提供)：RTL建议作为NICHD盆底疾病网络(PFDN)的数据协调中心(DCC)，以支持其通过进行精心设计的、足够强大的诊断、预防和治疗研究来改善盆底疾病(PFDs)妇女的护理的使命。我们将利用我们作为DCC支持多中心NIH临床研究网络的35年经验，通过数据管理和后勤服务，在研究设计和数据分析以及运营支持方面为网络提供统计领导地位。具体地说，我们将(1)合作制定、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)为数据安全监测委员会和网络委员会准备数据和安全报告；(4)合作分析数据和发布网络研究结果；(5)协调研究材料和生物标本处理；以及(6)提供所有其他后勤支持，包括运行高效和富有成效的网络所需的网络会议和通信。这项应用具有特定的优势，将提高PFDN的科学生产率：(1)丹尼斯·华莱士博士的科学领导，他作为高级临床生物统计师和多站点NIH研究网络的首席研究员，拥有18年以上的经验。(2)来自RTL和北卡罗来纳大学教堂山分校(UNC)的生物统计学、外科手术、行为和生活质量结果；成本效益和方案评估；以及定性和定量调查的多学科专家，他们将与PFDN调查人员合作，以：(A)开发创新试验设计(在必要时为方法进步进行形成性研究)以解决盆底试验中的独特问题；(B)开发和实施新的结果衡量标准；(C)利用试验数据与设计良好的二次观察性研究来回答重要的辅助问题；以及(D)快速应对网络分析需求的波动。(3)一种最先进、灵活和全面的基于网络的分布式数据输入和管理系统，该系统将(A)确保高质量的数据，具有快速错误解决、实时登记和不良事件监测；(B)为疑难问题提供创造性的解决方案，如收集患者报告的结果；以及(C)为现场工作人员提供研究管理和报告工具，以提高临床现场试验活动的科学质量和效率。 相关性：PFDN成立于2001年，旨在通过进行精心设计的、严格的临床试验和诊断、预防和治疗研究，改善对患有PFDs的妇女的护理。DCC为这样一个富有成效的多中心研究企业提供必要的生物统计学和临床试验专业知识，确保标准化的研究设计和开发，以及数据收集和分析，使用独立的统计专业知识来制定、设计、监测和分析随机对照试验，并在不同的临床站点之间提供通信和后勤支持，以优化网络的效率和生产力。

DESCRIPTION (provided by applicant): RTl proposes 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, adequately powered studies of diagnosis, prevention, and treatment. We will draw upon our 35 years of experience as a DCC supporting multicenter NIH clinical research networks to provide the Network 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 data and safety reports for the Data Safety Monitoring Board and Network committees; (4) collaborate in the analysis of data and publication of results of Network studies; (5) coordinate acquisition of study materials and biological specimen processing; and (6) provide all other logistical support, including Network meetings and communication necessary to run an efficient and productive Network. This application has specific strengths that will enhance the scientific productivity of the PFDN: (1) Scientific leadership of Dr. Dennis Wallace, with more than 18 years experience as a senior clinical biostatistician and Principal Investigator for multisite NIH research networks. (2) Multidisciplinary experts, from RTl and The University of North Carolina, Chapel Hill (UNC), in biostatistics; surgical, behavioral, and quality of life outcomes; cost-effectiveness and program evaluation; and qualitative and quantitative surveys, who will collaborate with PFDN investigators to (a) develop innovative trial designs (conducting formative research for methodological advancements if needed) to address the unique problems in pelvic floor trials; (b) develop and implement new outcome measures; (c) leverage trial data with well-designed secondary observational studies that answer important ancillary questions; and (d) respond quickly to fluctuations in Network analytic needs. (3) A state-of-the art, flexible, and comprehensive web-based distributed data entry and management system that will (a) ensure high-quality data with rapid error resolution and real-time enrollment and adverse event monitoring; (b) provide creative solutions to difficult problems, like collecting patient-reported outcomes; and (c) provide site staff with study management and reporting tools that enhance the scientific quality and efficiency of clinical site trial activities. RELEVANCE: The PFDN was established in 2001 to improve the care of women with PFDs by conducting well-designed, rigorous clinical trials and studies of diagnosis, prevention, and treatment. A DCC provides essential biostatistical and clinical trials expertise to such a productive multicenter research enterprise and ensures standardized study design and development, and data collection and analyses, using independent statistical expertise to formulate, design, monitor, and analyze RCTs and provides communications and logistical support between the disparate clinical sites to optimize the efficiency and productivity of the Network.