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.
(provided by the applicant): NAFLD has emerged as a major risk factor for diabetes and cardiovascular disease in the past decade. While 5% of subjects with a fatty liver may progress to cirrhosis, NASH progresses to cirrhosis in 15% of subjects. This means that about 6 million Americans are at risk of developing cirrhosis from NAFLD;many of these are children.
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