# University of North Carolina Clinical Center for DILIN

> **NIH NIH U01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $349,338

## Abstract

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.

## Key facts

- **NIH application ID:** 9994979
- **Project number:** 5U01DK065201-18
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** PAUL B WATKINS
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $349,338
- **Award type:** 5
- **Project period:** 2003-09-30 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9994979

## Citation

> US National Institutes of Health, RePORTER application 9994979, University of North Carolina Clinical Center for DILIN (5U01DK065201-18). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9994979. Licensed CC0.

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