Pelvic Floor Disorders Network Data Coordinating Center

项目摘要 RTI国际建议继续担任NICHD骨盆的数据协调中心（DCC） 盆底疾病网络（PFDN），以支持其改善女性盆底疾病护理的使命 通过进行精心设计的多中心观察性研究和临床试验， 诊断、预防和治疗。基于10年的PFDN DCC经验，RTI将提供 在研究设计、数据分析和通过数据提供业务支持方面具有统计领导力的网络 管理和后勤服务。具体而言，DCC将（1）领导创新的研究设计和分析 解决PFD研究的具体挑战，包括从实验室到床边的转化研究， 生物统计学、统计遗传学、心理测量学、卫生经济学、机器学习等方面的专业知识 与临床研究者合作，开发严格设计的研究， （2）提供沟通和协作工具，以促进 快速开发电子数据采集协议和网络系统（包括直接采集 通过移动的应用程序的患者报告结果）、生物样本跟踪、组学数据管道和培训; (3)在每项研究的整个生命周期内执行数据管理、质量保证和监查程序， 利用集中和远程监控功能，有效利用网络资源;（4）报告 数据质量、方案依从性和安全性，并进行统计分析， 国际会议，并在顶级期刊上发表;以及（5）协调远程和面对面 会议，管理分包合同，向研究中心提供自动按人头付费，并管理生物标本 运输和储存、研究药物采购以及设备和供应品分发（如需要），以支持 网络研究。Dr.玛丽Zuez作为DCC主要研究者（PI）和Dr. Sonia托马斯作为候补PI将 在下一个PFDN周期中提供经证明的DCC领导的连续性。他们由一个团队支持， 丰富的PFD研究经验，可灵活调整人员配置并引入额外的专业知识， 需要支持PFDN不断变化的需求。

Project Summary RTI International 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. Building on 10 years of experience as PFDN DCC, RTI will provide the Network with statistical leadership in study design and data analysis and operational support through data management and logistical services. Specifically, the DCC will (1) lead innovative study designs and analyses to address challenges specific to PFD research, including bench-to-bedside translational studies, by providing expertise in biostatistics, statistical genetics, psychometrics, health economics, machine learning, and other fields and collaborating with clinical investigators to develop rigorously designed studies with outcome measures important to women with PFDs; (2) provide tools for communication and collaboration to facilitate rapid development of protocols and web-based systems for electronic data capture (including direct capture of patient-reported outcomes via mobile applications), biospecimen tracking, omics data pipelines, and training; (3) conduct data management, quality assurance, and monitoring procedures throughout the life of each study, capitalizing on centralized and remote monitoring capabilities for efficient use of network resources; (4) report on data quality, protocol adherence, and safety, and perform statistical analysis for presentation at national and international conferences, and publication in top-tiered journals; and (5) coordinate remote and in-person meetings, manage subcontracts, provide automatic capitation payments to sites, and manage biospecimen transport and storage, study drug acquisition, and equipment and supplies distribution as needed to support network studies. Dr. Marie Gantz as DCC Principal Investigator (PI) and Dr. Sonia Thomas as Alternate PI will provide continuity of proven DCC leadership into the next PFDN cycle. They are supported by a team with extensive PFD research experience, with flexibility to adjust staffing and bring in additional expertise as needed to support the evolving needs of the PFDN.