The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has proposed the continuation and expansion of the Drug-Induced Liver Injury Network (DILIN). As described in the RFA, DILIN will evolve into a network of up to 8 Clinical Centers (CCs), the Data Coordinating Center (DCC), and the NIDDK Project Office. The purpose of this research program is to enhance the enrollment of cases and controls from a wide demographic and geographic distribution, devise testable hypotheses to assess the role of genetic variability in DILI, perform pharmacogenetic analysis and develop the infrastructure needed to find phenotypic-genotypic associations, disseminate the information to the greater scientific community, and develop, in conjunction with the National Library of Medicine, an authoritative and complete internet website for drug-induced liver injury. The Duke Clinical Research Institute (DCRI) proposes to continue as the DCC for DILIN. In this role, we will apply our extensive experience and research infrastructure to coordinate, support and facilitate the activities of the network. In particular, we will attend to the following specific aims: (1) nurture the efficient organizational structure developed in the initial grant period;(2) invoke quality assurance procedures to ensure fidelity in conducting these studies;(3) integrate the new clinical centers into DILIN;(4) maintain data management systems developed in the initial grant period to safeguard the completeness, accuracy and timeliness of the accumulating data;(5) continue reports developed in the initial grant period to chart progress in conducting these studies;(6) contribute in a substantive manner to design and conduct of pharmacogenetic studies;(7) contribute to the NLM initiative to developed an authoritative DILI website;(8) contribute to the development of a validated, diagnostic instrument for DILI;(9) provide appropriate and capable leadership and expertise in biostatistics and study design;and (10) support ancillary studies and prospective studies.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK065176-10
Application #
8330958
Study Section
Special Emphasis Panel (ZDK1-GRB-8 (O1))
Program Officer
Serrano, Jose
Project Start
2003-09-30
Project End
2013-06-30
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
10
Fiscal Year
2012
Total Cost
$1,448,999
Indirect Cost
$444,675
Name
Duke University
Department
Biostatistics & Other Math Sci
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Schmeltzer, Paul A; Kosinski, Andrzej S; Kleiner, David E et al. (2016) Liver injury from nonsteroidal anti-inflammatory drugs in the United States. Liver Int 36:603-9
Heidemann, Lauren A; Navarro, Victor J; Ahmad, Jawad et al. (2016) Severe Acute Hepatocellular Injury Attributed to OxyELITE Pro: A Case Series. Dig Dis Sci 61:2741-8
deLemos, Andrew S; Ghabril, Marwan; Rockey, Don C et al. (2016) Amoxicillin-Clavulanate-Induced Liver Injury. Dig Dis Sci 61:2406-16
Bonkovsky, Herbert L; Kleiner, David E; Gu, Jiezhun et al. (2016) Clinical Presentations and Outcomes of Bile Duct Loss caused by Drugs and Herbal and Dietary Supplements. Hepatology :
Zheng, Elizabeth X; Rossi, Simona; Fontana, Robert J et al. (2016) Risk of Liver Injury Associated with Green Tea Extract in SLIMQUICK(®) Weight Loss Products: Results from the DILIN Prospective Study. Drug Saf 39:749-54
Vuppalanchi, Raj; Navarro, Victor; Vega, Maricruz et al. (2015) Herbal dietary supplement associated hepatotoxicity: an upcoming workshop and need for research. Gastroenterology 148:480-2
Chalasani, Naga; Bonkovsky, Herbert L; Fontana, Robert et al. (2015) Features and Outcomes of 899 Patients With Drug-Induced Liver Injury: The DILIN Prospective Study. Gastroenterology 148:1340-52.e7
Hayashi, Paul H; Barnhart, Huiman X; Fontana, Robert J et al. (2015) Reliability of causality assessment for drug, herbal and dietary supplement hepatotoxicity in the Drug-Induced Liver Injury Network (DILIN). Liver Int 35:1623-32
Hayashi, Paul H; Fontana, Robert J; Chalasani, Naga P et al. (2015) Under-reporting and Poor Adherence to Monitoring Guidelines for Severe Cases of Isoniazid Hepatotoxicity. Clin Gastroenterol Hepatol 13:1676-82.e1
Martinez, Melissa A; Vuppalanchi, Raj; Fontana, Robert J et al. (2015) Clinical and histologic features of azithromycin-induced liver injury. Clin Gastroenterol Hepatol 13:369-376.e3

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