This proposal from the Johns Hopkins University Center for Clinical Trials (CCT) is for a Data Coordinating Center (DCC) to support the Non-Alcoholic Steato-Hepatitis (NASH) clinical research network. The network will focus on the etiology, natural history, and therapy of NASH. The goal of this consortium is to perform clinical, epidemiological, and therapeutic research in NASH in the United States. The DCC will work with the NIDDK and the Steering Committee (SC) to provide an infrastructure that can rapidly and efficiently design and conduct clinical trials for effective interventions to prevent disease progression. The DCC in collaboration with the SC will work to design, evaluate, and select studies for implementation by assembling and distributing materials needed to decide among design options. At the direction of the SC, the DCC will cull information from the literature or other sources and make sample size calculations needed to make informed selections of standardized outcome measures for each study. For the trials selected by the network, the DCC will play a leadership role in organizing their implementation, conduct, and quality control. The DCC will assume responsibility for all data analytic tasks needed for interim safety and efficacy monitoring and for presentations and publications from the trials. To support these activities, the DCC has assembled an interdisciplinary staff with trial-related expertise and experience in statistical design and analysis, clinical epidemiology, and obesity-related disease. Building from systems developed for ongoing studies coordinated by the CCT, the DCC will provide a comprehensive information management system to support network activities including the development and distribution of design documents (protocols, manuals, forms, policy memoranda, etc), a study website for up-to-date access to study-related materials, a distributed database management system for trial data capture and processing, a reporting system for monitoring recruitment performance and quality control, and analysis systems for interim and final data analysis. The DCC has biostatistical expertise to support the analytic needs of the network including design-specific determinations of sample size and power and the use of standard or non-standard methods for the analysis of data. The DCC will provide other support including the establishment of centralized laboratories, reading centers, or specimen banking resources (possibly through subcontracts, as needed).
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