Gastroparesis Consortium Continuation-Data Coordinating Center

胃轻瘫联盟延续-数据协调中心

• 批准号: 8730342
• 负责人: James A Tonascia
• 金额: $ 50万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-01 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8730342
• 关键词: Blood specimen; Clinic; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Code; Data; Data Analyses; Data Coordinating Center; Data Reporting; Databases; Development; Devices; Disease; Etiology; Gastroparesis; Genetic; Goals; Investigational Drugs; Lead; Maintenance; Manuscripts; Methods; Modification; Molecular; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Oral; Pathogenesis; Patients; Preparation; Procedures; Process; Protocols documentation; Public Health; Questionnaires; Registries; Reporting; Research; Risk; Sample Size; Sampling Studies; Shipping; Ships; United States Food and Drug Administration; Universities; Work; base; meetings; nutrition; protocol development; quality assurance; repository; treatment strategy; treatment trial

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.

描述（由申请人提供）：约翰霍普金斯大学的这项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个治疗试验（NORIG, GLUMIT-DG， APRON），并继续收集胃轻瘫患者和相关疾病的生物标本和数据。此外，DCC将支持Farrugia博士在明尼苏达州罗切斯特梅奥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。GpCRC自2006年起由NIDDK赞助，其目标是关注胃轻瘫的病因、治疗策略和临床病程。DCC将继续支持GpCRC，并负责支持任何协议的开发或修改；提供样本量计算、统计建议、问卷调查和数据分析；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控计划；支持稿件准备；并提供全面的研究协调和质量保证，包括协调指导委员会的活动和会议。在实施任何研究方案或方案变更之前，DCC将准备或修改方案，提交给数据和安全监测委员会（DSMB）和SC批准。DCC将负责准备提交给食品和药物管理局（FDA）的文件，以支持GPCRC的研究性新药（IND）或研究性器械豁免（IDE）申请。发展协调会将编写所有报告，包括数据报告，供发展协调会在其会议上审查。DCC将根据需要负责获得和管理分包合同。DCC将继续与NIDDK生物样本、遗传和数据存储库以及临床中心合作，协调将在存储库中维护的研究样本的编码、运输、处理、接收和存储程序。