The National Institute for Diabetes and Digestive and Kidney Diseases has solicited applications to initiate a Urinary Stone Disease Research Network (USDRN) to design and conduct a randomized clinical trial to 1) investigate the impact of increased fluid intake and increased urine output on urinary stone recurrence in adults and children; 2) conduct clinical research to understand and mitigate ureteral stent-related pain and symptoms; and, 3) provide data and collect biological samples from the studies to create a resource for future researchers. The Duke Clinical Research Institute (DCRI) proposes to serve as the Scientific Data Research Center to provide cutting edge thought leadership, trial innovation, infrastructure, clinical and research experience, and operational expertise necessary to support the research activities of the Network. As SDRC for the Network, the DCRI will support the following Specific Aims: 1) coordinate the overall activities of the USDRN, network committees and work with the NIDDK and Steering Committee to establish reliable and efficient communication structures; 2) facilitate pragmatic trial design and creation of a distributed research network based on prior experience with the NIH Collaboratory; 3) provide thought leadership and operational support for trial design and protocol development, including identification of relevant clinical endpoints, appropriate sample size/power calculations, randomization strategies, and the development of economic and patient- reported outcomes, as appropriate; 4) develop the network Manual of Procedures, provide training and certification for study personnel at all clinical centers, perform site monitoring and develop performance trackers; 5) develop and manage an Electronic Data Capture system, including training, quality control, data storage and reporting; 6) develop detailed and rigorous statistical analysis plans for each study; 7) facilitate DSMB activities including periodic statistical analysis reports and interim analyses; 8) organize and manage transfer of biological samples from clinical sites to the NIDDK biorepository; 9) Provide thought leadership in developing the USDRN dissemination strategy, including website management, editorial, technical and administrative support for all study publications, and working with the Steering Committee to effectively disseminate the findings of USDRN studies; and, 10) support ancillary studies and facilitate use of Network bio-specimens transmitted to the NIDDK Biorepository. Through innovative trial design, novel biostatistical methods and operational excellence, the DCRI as SDRC will advance the care of urinary stone disease patients and thereby improve outcomes and reduce the burden of stone disease in the United States.
The DCRI will support innovations in clinical trials that will allow the USDRN to achieve landmark trials and clinical investigations over the next 5 years. The results of the initial USDRN trials will change professional guidelines, provide additional data for future outcomes trials, and will ultimately improve clinical care of patients suffering from urinary stone disease.
