Pelvic Floor Disorders Network Data Coordinating Center

项目总结

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.