The NIDDK has proposed a research program to establish and maintain the infrastructure for a Hepatotoxicity Clinical Research Network (HCRN). This network will comprise 4-5 Clinical Centers (CCs) and a Data Coordinating Center (DCC). The primary objective of the HCRN is to develop standardized instruments to identify and fully characterize bona fide cases of drug-, CAM- and toxin-induced liver injury. This will allow for an investigation of the full epidemiological and clinical spectrum of hepatotoxicity. Biological samples will be obtained for the study of the pathogenesis of hepatotoxicity using biochemical, serological and genetic techniques. This initiative will expand current understanding of the mechanisms of drug and toxin-induced liver injury and provide the basis for more effective and safer medical therapies. The Duke Clinical Research Institute (DCRI) proposes to serve as the Data Coordinating Center for this project. In this role, we will apply our considerable experience and resources to coordinate and facilitate the activities of this study and to ensure that scientifically defensible conclusions can be drawn. In particular, we will attend to the following functions: (1) Study Coordination: an efficient organizational structure will be established to ensure that activities advance in a coordinated fashion. (2) Site Management and Monitoring: we will develop a site management plan to safeguard the integrity of the accumulating data. (3) Data Management Activities: we will apply a comprehensive system for on-going data collection and generate reports summarizing progress in the conducting the study. (4) Statistical Analysis: we will provide statistical leadership in the design of these studies, and perform statistical analyses in an expeditious and timely manner.
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