The UNC Clinical Center has continued to be the leader among the six DILIN centers in terms of total subject recruitment, recruitment of African Americans, and recruitment of people with liver injury due to herbal and dietary supplements. We have also led in the proposal and execution of ancillary studies. Dr. Watkins has served as the Chair of the Steering and Executive Committees since the network?s inception in 2003, and chair of the Genetics Subcommittee since 2008. Dr. Hayashi is co-chair of the Causality Assessment Subcommittee. Dr. Bonkovsky oversees enrollment within the Wake Forest Health Care system and has been a leader in ancillary study proposal and execution. In the next 5 years, we propose to continue our center?s leadership roles as the network strives to attain the three stated goals of the RFA: 1) Clinical, biochemical, histologic and biologic characterization of DILI. We will remain the leader in total subject recruitment and in genetic and non-genetic biomarker research. We will extend our already substantial lead in recruitment of African Americans and patients with liver injuries attributed to herbal and dietary supplements through new collaborations with Dr. Hans Tillman at Eastern Carolina University and Dr. Vito Cirigliano at Womack Army Medical Center, respectively. We will also continue our lead in biomarker research through international collaborations, and promising UNC junior faculty have already submitted a DILIN-linked RO1 application and a second application will soon be submitted. 2) Develop pilot/feasibility studies that would lay the groundwork for future studies on treatment of severe DILI. We have successfully demonstrated the ability to enroll acute DILI cases and have taken the lead in identifying novel biomarkers that may better predict outcome of DILI at study entry and thereby better target the appropriate patients for more aggressive therapeutic intervention. 3) Pharmacovigilance of HDS and newly approved prescription medications (collaboration with FDA) and public resource for accurate information on DILI (DILIN centers and Livertox). Dr. Watkins and our two co-investigators will continue to be very active on the causality assessment committee and reporting to the FDA, and will participate in all activities related to improving the Livertox website and a web-based causality assessment instrument.
Drug-induced liver injury remains a major problem for patients, physicians and regulators. The data and tissue banks created by the DILIN network provide the needed resources to understand and solve this important public health problem.
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