Continuation of the Non-Alcoholic Steatohepatitis Clinical Research Network (NASH

非酒精性脂肪性肝炎临床研究网络（NASH

• 批准号: 8012483
• 负责人: James A Tonascia
• 金额: $ 7.5万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-02-01 至 2011-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8012483
• 关键词: Address; Adult; Affect; American; Ancillary Study; Archives; Attention; Biological Markers; Blood specimen; Burn injury; Cardiovascular Diseases; Cardiovascular system; Child; Cirrhosis; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Code; Collection; Control Groups; Data; Data Analyses; Data Coordinating Center; Data Reporting; Databases; Development; Diabetes Mellitus; Diagnosis; Disease; Disease Progression; Double-Blind Method; Elements; Enrollment; Etiology; Fatty Liver; Feasibility Studies; Funding; Genetic; Goals; Histology; Investigational New Drug Application; Length; Liver; Liver diseases; Logistics; Longitudinal Studies; Maintenance; Manuscripts; Methods; Modification; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; North America; Pathogenesis; Patients; Performance; Phenotype; Preparation; Prevention; Procedures; Process; Proteomics; Protocols documentation; Questionnaires; Randomized; Randomized Clinical Trials; Reporting; Research; Risk; Risk Factors; Safety; Sample Size; Sampling; Sampling Studies; Serum; Shipping; Ships; Site; Specificity; Staging; Steatohepatitis; Systems Biology; Therapeutic; Therapeutic Studies; Therapy Clinical Trials; Time; Tissue Sample; United States Food and Drug Administration; United States National Institutes of Health; Universities; Work; base; clinical material; disease natural history; effective therapy; follow-up; insulin sensitizing drugs; liver biopsy; meetings; metabolomics; non-alcoholic fatty liver; non-diabetic; nonalcoholic steatohepatitis; prospective; protocol development; public health relevance; quality assurance; repository; sobriety; tool; treatment trial

DESCRIPTION (provided by applicant): This proposal from the Johns Hopkins University is to continue as the Data Coordinating Center (DCC) of the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network to support the Clinical Centers (CC) as they complete two treatment trials, one in adults and one in children, and continue to gather biospecimens and data of children and adults with nonalcoholic fatty liver disease (NAFLD), including steatohepatitis and cirrhosis (NAFLD Database study). The overall goal of the NASH Clinical Research Network (CRN) sponsored by the NIDDK since 2002 is to focus on the etiology, contributing factors, natural history, complications, and therapy of NASH. The DCC will continue to support the NASH CRN 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 safety and monitoring plans; supporting manuscript preparation; and providing overall study coordination and quality assurance, including coordination of the activities and meetings of the Data and Safety Monitoring Board (DSMB), the Steering Committee (SC), and other committees. The DCC will prepare or modify protocols for submission to the 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 Applications (INDs) held by the NIDDK on behalf of the NASH CRN. The DCC will also prepare all reports including data reports for review by the DSMB at their meetings. The DCC will also be responsible for the logistics and planning of the meetings of the SC and the various operational committees of the NASH CRN. 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 CCs to coordinate procedures for coding, shipping, processing, receipt, and storage of study samples that are to be maintained in the Repositories.

描述（由申请人提供）： 约翰霍普金斯大学的这一提议是继续作为非酒精性脂肪性肝炎（NASH）临床研究网络的数据协调中心（DCC），以支持临床中心（CC）完成两项治疗试验，一项在成人中，一项在儿童中，并继续收集非酒精性脂肪性肝病（NAFLD）儿童和成人的生物标本和数据，包括脂肪性肝炎和肝硬化（NAFLD数据库研究）。自2002年以来，NIDDK赞助的NASH临床研究网络（CRN）的总体目标是专注于NASH的病因，促成因素，自然史，并发症和治疗。DCC将继续支持NASH CRN，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安全性和监测计划;支持手稿准备;并提供总体研究协调和质量保证，包括协调数据和安全性监查委员会（DSMB）、指导委员会（SC）和其他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将编制或修改方案，以提交给DSMB和SC批准。DCC将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NIDDK代表NASH CRN持有的研究性新药申请（IND）。DCC还将编写所有报告，包括数据报告，供DSMB在其会议上审查。DCC还将负责SC和NASH CRN各运营委员会会议的后勤和规划。DCC将负责根据需要获取和管理分包合同。DCC将继续与NIDDK生物样本、遗传和数据储存库以及CC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。