This proposal from the Johns Hopkins University is to continue as the Scientific Data Research Center (SDRC) of the Gastroparesis Clinical Research Consortium (GpCRC) to support the clinical centers as they continue to gather biospecimens and data for patients with gastroparesis and related disorders in the Gastroparesis Registry 2 and future treatment trials. In addition, the SDRC will support the Pathological Basis of Gastroparesis Study conducted by Dr. Farrugia at the Mayo Clinic in Rochester, MN for identification of the molecular factors involved in pathogenesis of gastroparesis. The goal of the GpCRC sponsored by the NIDDK since 2006 is to focus on the etiology, treatment strategies, and clinical course of gastroparesis that will provide the basis for understanding the natural history and developing means of better diagnosis, treatment, and clinical management of patients with gastroparesis. In the next phase of the GpCRC, the studies initiated during the previous funding cycle will be completed, and new therapeutic trials will be initiated. The SDRC will provide the GpCRC with leadership, expertise in biostatistical analysis, study design, data management, multicenter coordination, quality assurance, project support, communication and organization, and will be responsible for supporting all future protocol development or modifications, including providing sample size calculations, statistical advice, development of questionnaires, and data analysis. The SDRC will support development, implementation, and maintenance of a database of clinical information and a digital repository for autonomic function, wireless motility capsule, and scintigraphy studies. The SDRC will work with the centers and the NIDDK Repository to track and maintain an inventory of all biospecimens obtained. The SDRC will develop or modify any data monitoring plans, support manuscript preparation, and coordinate the activities and meetings of the Steering Committee (SC). The SDRC will prepare or modify protocols for submission to the Data and Safety Monitoring Board (DSMB) and the SC for their approval prior to the implementation of any study protocols or protocol changes. The SDRC will be responsible for preparation of documents for submission to the Food and Drug Administration (FDA) in support of Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications on behalf of the GpCRC. The SDRC will prepare all reports including data reports for review by the DSMB at their meetings. The SDRC will be responsible for acquiring and administering subcontracts as needed. The SDRC and will continue to work with the NIDDK Biosample, Genetic, and Data Repositories, and the clinical centers to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repositories. The GpCRC is poised to continue to have major impact on the field and directly advance the mission of the National Institutes of Health to improve the health of the public.
Gastroparesis is a disorder of gastric function characterized by delay in gastric emptying and frequently associated with chronic nausea and vomiting, early satiety, and abdominal pain. Gastroparesis is a disease affecting predominantly young women which can have a devastating impact on quality of life. The GpCRC aims to transform scientific discoveries from laboratory, clinical, and population studies into clinical applications to improve treatments and reduce the burden of adverse outcomes due to gastroparesis.
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