{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Treem WR"],"funding":["NIDDK NIH HHS","NIGMS NIH HHS"],"pagination":["133-165"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC7847464"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["44(2)"],"pubmed_abstract":["With the widespread development of new drugs to treat chronic liver diseases (CLDs), including viral hepatitis and nonalcoholic steatohepatitis (NASH), more patients are entering trials with abnormal baseline liver tests and with advanced liver injury, including cirrhosis. The current regulatory guidelines addressing the monitoring, diagnosis, and management of suspected drug-induced liver injury (DILI) during clinical trials primarily address individuals entering with normal baseline liver tests. Using the same laboratory criteria cited as signals of potential DILI in studies involving patients with no underlying liver disease and normal baseline liver tests may result in premature and unnecessary cessation of a study drug in a clinical trial population whose abnormal and fluctuating live"],"journal":["Drug safety"],"pubmed_title":["Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis."],"pmcid":["PMC7847464"],"funding_grant_id":["P20 GM130457","P30 DK123704"],"pubmed_authors":["Dash A","Maller E","Patwardhan M","Freston JW","Chalasani N","Lonjon-Domanec I","Lewis JH","Andrade RJ","Treem WR","Di Bisceglie AM","Rockey DC","Dimick-Santos L","Regev A","Seekins D","Palmer M","Avigan MI","Marcinak JF"],"additional_accession":[]},"is_claimable":false,"name":"Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis.","description":"With the widespread development of new drugs to treat chronic liver diseases (CLDs), including viral hepatitis and nonalcoholic steatohepatitis (NASH), more patients are entering trials with abnormal baseline liver tests and with advanced liver injury, including cirrhosis. The current regulatory guidelines addressing the monitoring, diagnosis, and management of suspected drug-induced liver injury (DILI) during clinical trials primarily address individuals entering with normal baseline liver tests. Using the same laboratory criteria cited as signals of potential DILI in studies involving patients with no underlying liver disease and normal baseline liver tests may result in premature and unnecessary cessation of a study drug in a clinical trial population whose abnormal and fluctuating live","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Feb","modification":"2025-04-18T15:58:47.332Z","creation":"2021-02-21T07:25:23Z"},"accession":"S-EPMC7847464","cross_references":{"pubmed":["33141341"],"doi":["10.1007/s40264-020-01014-2"]}}