Gastroparesis Consortium Continuation-Data Coordinating Center

描述（由申请人提供）：约翰霍普金斯大学的这份提案是继续作为胃轻瘫临床研究联盟（GPCRC）的数据协调中心（DCC），以支持临床中心完成三项治疗试验（NORIG、GLUMIT-DG、APRON），并继续收集胃轻瘫登记研究中胃轻瘫和相关疾病患者的生物标本和数据。此外，DCC将支持Farrugia博士在明尼苏达州罗切斯特的马约诊所进行的胃轻瘫病理基础研究，以确定参与胃轻瘫发病机制的分子因素。自2006年以来，由NIDDK赞助的GpCRC的目标是关注胃轻瘫的病因、治疗策略和临床过程。DCC将继续支持GpCRC，并将负责支持任何方案制定或修改;提供样本量计算、统计建议、问卷和数据分析;支持临床信息和血液样本数据库的开发、实施和维护;制定或修改任何数据监查计划;支持手稿准备;并提供总体研究协调和质量保证，包括协调指导委员会（SC）的活动和会议。在实施任何研究方案或方案变更之前，DCC将编写或修改方案，以提交给数据和安全性监查委员会（DSMB）和SC批准。DCC将代表GPCRC负责准备提交给美国食品药品监督管理局（FDA）的文件，以支持新药临床试验（IND）或试验用器械豁免（IDE）申请。DCC将准备所有报告，包括数据报告，供DSMB在其会议上审查。发展协调委员会将负责根据需要获得和管理分包合同。DCC将继续与NIDDK生物样本、遗传和数据储存库以及临床中心合作，协调储存库中保存的研究样本的编码、运输、处理、接收和储存程序。 公众相关性：到目前为止，胃轻瘫联盟的研究强调了胃轻瘫的公共卫生意义，包括需要开发有效的胃轻瘫管理方法，需要识别有进展为更严重胃轻瘫风险的患者（包括无法维持口服营养的患者），以及需要识别导致胃轻瘫的关键细胞变化。

DESCRIPTION (provided by applicant): This proposal from the Johns Hopkins University is to continue as the Data Coordinating Center (DCC) of the Gastroparesis Clinical Research Consortium (GPCRC) to support the clinical centers as they complete three treatment trials (NORIG, GLUMIT-DG, APRON) and continue to gather biospecimens and data for patients with gastroparesis and related disorders in the Gastroparesis Registry. In addition, the DCC will support the Pathological Basis of Gastroparesis Study conducted by Dr. Farrugia at the Mayo Clinic in Rochester, MN for identification ofthe molecular factors involved in pathogenesis of gastroparesis. The goal ofthe GpCRC sponsored by the NIDDK since 2006 is to focus on the etiology, treatment strategies, and clinical course of gastroparesis. The DCC will continue to support the GpCRC and will be responsible for supporting any protocol development or modifications; providing sample size calculations, statistical advice, questionnaires, and data analysis; supporting development, implementation, and maintenance of a data base of clinical information and blood samples; developing or modifying any data monitoring plans; supporting manuscript preparation; and providing overall study coordination and quality assurance, including coordination ofthe activities and meetings of the Steering Committee (SC). The DCC 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 change. The DCC 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 DCC will prepare all reports including data reports for review by the DSMB at their meetings. The DCC will be responsible for acquiring and administering subcontracts as needed. The DCC 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. PUBLIC RELEVANCE: Gastroparesis Consortium's research so far underscores the public health significance of gastroparesis including the need to develop effective methods for management of gastroparesis, the need to identify patients who are at risk of progression to more severe gastroparesis (including patients who are unable to maintain oral nutrition), and the need to identify the key cellular changes that lead to gastroparesis.