IQ DILI Initiative ABNORMAL BASELINE Working Group
Nonmember Solicitation
Ajit Dash, Genentech
John Marcinak, AbbVie
October 2, 2024
Background and Rationale
Due to the high world-wide prevalence of chronic liver diseases (CLD) such as viral hepatitis, metabolic dysfunction-associated fatty liver disease, alcohol-related liver disease, and metastatic liver disease, the number of patients with pre-existing CLD who are enrolled in clinical trials has increased substantially. Despite intensive research, there are still limited data regarding the phenotype, natural history and clinical outcome of drug-induced liver injury (DILI) in clinical trial participants with underlying CLD. In addition, published regulatory guidelines do not address issues related to the detection, monitoring and management of suspected DILI in such patients. The Abnormal Baseline Working Group has published consensus papers addressing best practices pertaining to DILI in patient with nonalcoholic steatohepatitis (NASH), patients with cholestatic liver diseases and patients with chronic viral hepatitis and cirrhosis due to Hepatitis B, C and NASH. The group is actively working on a number of projects including a data sharing project to study the Fluctuations in Laboratory Tests in Patients Receiving Placebo in NASH Clinical Trials. This project requires strong expertise in hepatology as well as knowledge and experience in Drug-induced liver injury (DILI) and in drug development.
Project Details
The Abnormal Baseline Working Group has been working on a pilot project for data sharing. The focus is data to address the gaps in the current knowledge regarding the phenotypes and natural history of liver test elevations in patients with NASH in order to differentiate the natural history of disease from DILI. A non-member participant with the necessary background, expertise and experience in the fields of hepatology and DILI as well as background in drug development would be an invaluable addition to support our working group in analyzing the results and drafting the manuscript for this data sharing project. In addition, a strong background in drug safety and the regulatory requirements related to clinical trials and drug registration would enhance the group’s capability to interpret the available data and reach consensus with regulatory and academic participants.
Qualifications (all are necessary)
· Involvement in the design/conduct/analysis/interpretation of interventional clinical trials in patients with liver diseases
· Experience with authoring scientific publications in the field of clinical hepatology and DILI
· Experience with acute, chronic and progressive liver diseases including NASH which might be confounders in potential cases of DILI
· Experience in pharmaceutical industry doing registration grade clinical trials for new drugs with experience in monitoring for, diagnosing, and managing potential DILI during these clinical trials.
Respondents, please note this is a volunteer role.
When this project is completed, membership with this IQ working group ends.
Please send your response to info@iqdili.org, including a current CV, by October 16, 2024.