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

项目摘要/摘要 自2006年以来，胃轻瘫临床研究联盟(GpCRC)在 成人和儿童胃轻瘫的发病机制、诊断、治疗和临床处理。这个 成人胃瘫的发病率为每10万人年6.3至17.2例，情况相似 对其他重要的胃肠道疾病，如炎症性肠病。这项提议将继续下去 作为科学数据研究中心(SDRC)，支持临床中心继续收集数据 以及用于有胃瘫症状的成人和儿童患者的生物素。国家发改委包括 Grover和Farrugia博士在梅奥诊所进行的胃轻瘫研究(PBG)的病理学基础 继续他们对胃轻瘫发病机制的分子因素的鉴定。我们的目标是 继续：1)完成丁螺环酮治疗早饱和胃瘫症状的成人试验， 幽门括约肌异常(PSAGS)研究和成人和儿童胃瘫登记启动 在上一个供资周期内；2)开发和进行新的成人或儿科治疗试验；以及3) 协调和实施单一内部审查委员会(SIRB)的使用，以监督所有正在进行的和未来的GpCRC研究。 国家发改委将在生物统计分析、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的 协议，包括提供样本量计算、统计咨询、表格开发、数据分析和 手稿准备工作。国家发改委将支持开发、实施和维护实时 数据库为每项研究，准备去确定的数据库提交给NIDDK中央资料库供公众- 使用和维护程序输出和标本化验或基因组数据的数字存储库。国家发改委将 协调指导委员会(SC)和其他委员会的活动和会议，并准备 向包括SC和数据与安全监测委员会(DSMB)在内的委员会提交报告。国家发改委将 准备提交给SC、NIDDK计划办公室和DSMB的协议，以及支持材料 研究新药(IND)或研究设备豁免(IDE)申请代表 NIDDK。国家发改委将支持GpCRC调查人员和专家科学家之间的合作伙伴关系，以使用 GpCRC资源，促进对胃轻瘫的认识。发改委将对绩效进行管理- 基于与临床中心的分包合同，以备将来可能出现的研究。国家发改委将协调 临床中心生物标记物的制备、编码和运送至NIDDK中央资料库及工作 使用存储库管理生物检疫物质的接收和库存以供存储和履行调查员 样本和数据要求。国家发改委将管理GpCRC的制定、审批和修订工作 政策声明、辅助研究、演示文稿和出版物。

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.