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

项目总结/摘要 自2006年以来，胃轻瘫临床研究联盟（GpCRC）在以下方面取得了进展： 发病机制，诊断，治疗和成人和儿童胃轻瘫的临床管理。的 成年人胃轻瘫的发病率范围为6.3 - 17.2例/100，000人-年， 其他重要的胃肠道疾病，如炎症性肠病。这项建议将继续下去， 作为科学数据研究中心（SDRC），支持临床中心继续收集数据 以及具有胃轻瘫症状的成人和儿童患者的生物标本。SDRC包括 由Grover和Farrugia博士在马约诊所进行的胃轻瘫研究（PBG）的病理学基础， 继续鉴定参与胃轻瘫发病机制的分子因素。我们的目标是 继续进行的是：1）完成丁螺环酮用于早饱和胃轻瘫症状的成人试验， 幽门括约肌痉挛（PSAGS）研究以及成人和儿童胃轻瘫登记研究启动 在上一个资助周期内; 2）开发和进行新的成人或儿童治疗试验;以及3） 协调并实施使用单一IRB（sIRB）来监督所有正在进行和未来的GpCRC研究。 SDRC将在生物统计分析、研究设计、数据管理、 多中心协调，质量保证，并将负责支持所有当前和未来 协议，包括提供样本量计算，统计咨询，表格开发，数据分析和 手稿准备。SDRC将支持开发、实施和维护实时 每个研究的数据库，准备去识别数据库提交给NIDDK中央存储库供公众使用- 使用和维护程序输出和样本分析或基因组数据的数字存储库。SDRC将 协调指导委员会（SC）和其他委员会的活动和会议，并准备所有 向委员会（包括SC和数据与安全性监查委员会（DSMB））提交报告。SDRC将 准备方案，连同支持材料沿着提交给SC、NIDDK项目办公室和DSMB 研究性新药（IND）或研究性器械豁免（IDE）申请 NIDDK。SDRC将支持GpCRC调查人员和专家科学家之间的伙伴关系， GpCRC资源，以促进对胃轻瘫的理解。国家发展和改革委员会将管理业绩- 与临床中心签订分包合同，用于未来可能出现的研究。SDRC将协调 临床中心生物标本的制备、编码和运输至NIDDK中央储存库， 与储存库一起管理生物标本的接收和库存，以供储存和履行研究者 样本和数据请求。SDRC将管理GpCRC的开发、批准和修订 政策声明、辅助研究、介绍和出版物。

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.