Continuation of the Scientific Data Research Center (SDRC) of the Gastroparesis Clinical Research Consortium (GpCRC) 4

项目总结/文摘

Project Summary/Abstract Since 2006, the Gastroparesis Clinical Research Consortium (GpCRC) has made advancements in the pathogenesis, diagnosis, treatment, and clinical management of gastroparesis in adults and children. The incidence of gastroparesis ranges from 6.3 to 17.2 cases per 100,000 person-years in adults, which is similar to other important gastrointestinal diseases such as inflammatory bowel disease. This proposal is to continue as the Scientific Data Research Center (SDRC) to support the clinical centers as they continue to collect data and biospecimens for adult and pediatric patients with symptoms of gastroparesis. The SDRC includes the Pathological Basis of Gastroparesis Study (PBG) conducted by Drs. Grover and Farrugia at the Mayo Clinic to continue their identification of the molecular factors involved in pathogenesis of gastroparesis. Our aims for the continuation are: 1) To complete the adult trial of Buspirone for Early Satiety and Symptoms of Gastroparesis, the Pyloric Sphincter Abnormalities (PSAGS) study, and adult and pediatric gastroparesis registries initiated during the previous funding cycle; 2) To develop and conduct a new adult or pediatric treatment trial; and 3) To coordinate and implement use of a single IRB (sIRB) to oversee all ongoing and future GpCRC studies. The SDRC will provide leadership, expertise in biostatistical analysis, study design, data management, multicenter coordination, quality assurance, and will be responsible for supporting all current and future protocols, including providing sample size calculations, statistical advice, form development, data analysis and manuscript preparation. The SDRC will support development, implementation, and maintenance of a real-time database for each study, prepare de-identified databases to submit to the NIDDK Central Repository for public- use and maintain a digital repository of procedure output and specimen assay or genomic data. The SDRC will coordinate the activities and meetings of the Steering Committee (SC) and other committees, and prepare all reports for committees including the SC and Data and Safety Monitoring Board (DSMB). The SDRC will prepare protocols for submission to the SC, NIDDK program office, and DSMB, along with materials in support of Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications on behalf of the NIDDK. The SDRC will support partnerships between GpCRC investigators and expert scientists to use GpCRC resources to advance the understanding of gastroparesis. The SDRC will administer performance- based subcontracts with clinical centers for future studies that may arise. The SDRC will coordinate the preparation, coding and shipping of clinical center biospecimens to the NIDDK Central Repository and work with the Repository to manage the receipt and inventory of biospecimens for storage and fulfilling investigator specimen and data requests. The SDRC will manage the development, approval, and amendments of GpCRC policy statements, ancillary studies, presentations, and publications.