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.
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.
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