The purpose of this Funding Opportunity Announcement is to invite applicationsfor for clinical centers for the continuation of the Drug-Induced Liver Injury Network (DILIN). The DILIN Clinical Centers are the components of the Network to identify, enroll and clinically characterize patients eligible for the DILIN. The companion RFA (RFA-DK-22-508) seeks to continue the Data Coordinating Center for DILIN.
Drug-induced liver injury (DILI) is one of the more challenging forms of liver disease; both in diagnosis and management. Several hundred drugs, dietary and herbal supplements have been implicated in causing liver injury. Their clinical presentation can be highly variable and mimic almost any form of liver disease. Over the last 19 years, the DILIN throughout its publications has become the major source of information and progress in understanding the burden of drug-induced liver injury for clinicians, hepatologists, researchers, and the public at large in the US and Worldwide.
The Network has made major advances in the understanding of the clinical presentation and outcomes of liver injury due to drugs as well as herbal and dietary supplements (HDS). These advances have led to exploratory inroads on the pathogenesis of DILI. DILIN remains the only structured, systematic and prospective effort in the United States and world-wide to characterize drug and HDS induced liver injury. The ultimate aims of DILIN are to elucidate the clinical and pathophysiologic features of DILI so as to allow inroads into its understanding, treatment and prevention, thus decreasing the burden of this disease.
The Network's future research interests lie in four main areas:
1. Clinical, biochemical, histologic and biologic characterization of DILI including acute and chronic disease, HDS-induced injury, ethnic and racial differences, genetic studies, cytokines and immunological profiling.
2. Support of ancillary studies and collaborations (both domestic and foreign, with academic or industry investigators) on mechanisms of idiosyncratic liver injury that might lead to insights into pathogenesis and approaches to prevention or treatment.
3. Pilot/feasibility studies that would lay the groundwork for future studies on treatment of severe acute DILI and chronic symptomatic cases.
4. Pharmacovigilance of HDS and newly approved prescription medications (in collaboration with the Food and Drug Administration) and public resource for accurate information on DILI (DILIN centers and LiverTox).
Applications focused on basic and animal studies of DILI will not be considered responsive to this FOA.
Deadlines:
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Letter of Intent Due Date(s): September 27, 2022
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Application Due Date: October 27, 2022
RFA-DK-22-013 Expiration Date October 28, 2022
The awards to each Clinical Center will be up to $250,000 in direct costs. Patient Care Cost should not be included in the application as it will be administered and provided by the DCC for all the CCs. Application budgets are not limited, but need to reflect actual needs of the proposed project. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.