Liver injury due to prescription drug and non-prescription drugs or Herbal and Dietary supplement (HDS) is an important medical, scientific, and public health problem in the United States. Drug-induced liver injury (DILI) is the most common reason for non-approval, withdrawal, limitation in use, and clinical monitoring by the Food and Drug Administration (FDA). The National Institute of Diabetes and Kidney Diseases (NIDDK) of the National Institute of Health established the Drug Induced liver injury Network (DILIN) in 2003 and has proposed the continuation of the DILIN. As described in the RFA, the DILIN will be a network composed of six Clinical Centers (CCs) to identify and enroll patients eligible for DILIN and one Data Coordinating Center (DCC) to provide managerial, logistic, and analytic functions for the DILIN. The future areas of the network study is to continue the clinical, biochemical, histologic and biologic characterization of DILI, to lay groundwork for future studies of treating severe DILI and to engage pharmacovigilance with information on DILI. The Duke Clinical Research Institute (DCRI) proposes to continue as the DCC for the DILIN. In this role, we will apply our extensive experience and research infrastructure to coordinate, support and facilitate the activities of the DILIN network. In particular, we will attend to the following specific aims: (1) Support the analytic core with chemical analyses of herbal and dietary supplements; (2) Provide statistical leadership to identify genetic and non-genetic biomarkers for DILI and to design treatment trial to improve the natural history of DILI; (3) Support manuscript preparation and ancillary studies; (4) Provide overall network coordination and logistics; (5) Ensure quality assurance and continue data management activities; (6) Contribute to maintain LiverTox.
Liver injury due to medication or herbal and dietary supplement use is an important medical, scientific, and public health problem in the US. Drug-induced liver injury (DILI) and it is the most common reason for non-approval, withdrawal, and clinical monitoring by the Food and Drug Administration. The National Institute of Diabetes and Kidney Diseases (NIDDK) of the National Institute of Health established the Drug Induced liver injury Network (DILIN) in 2003 and the DILIN will continue for another five years. The future areas of the network study is to continue the clinical, biochemical, histologic and biologic characterization of DILI, to lay groundwork for future studies of treating severe DILI and to engage pharmacovigilance with information on DILI. By supporting the DILIN as the DCC, we seek to understand the clinical and genetic determinants of DILI. This should lead to major advances in our understanding of the mechanism(s) of DILI as well DILI diagnosis, management and treatment. Ultimately it allows safe medications to be prescribed to patient populations and safe supplements on the market.
| Hayashi, Paul H; Rockey, Don C; Fontana, Robert J et al. (2017) Death and liver transplantation within 2 years of onset of drug-induced liver injury. Hepatology 66:1275-1285 |
