IQ Consortium Drug-Induced Liver Injury Initiative

In collaboration with the IQ Drug Induced Liver Injury Initiative (IQ DILI), nonalcoholic steatohepatitis (NASH) and DILI experts from across academia, industry, and US FDA have collaborated to develop comprehensive guidelines addressing best practices for detection, assessment and management of DILI in clinical trials. Their findings, featured in Alimentary Pharmacology & Therapeutics, are based on extensive literature review and discussions between numerous drug safety & DILI subject matter experts to achieve consensus on common questions related to this crucial topic. The publication is available here.

NASH is presently the most common cause of chronic liver disease worldwide, and a leading indication for liver transplantation in the Western world. Over the last decade, there has been an acceleration in the search for new therapies for NASH, and the number of clinical trials enrolling NASH patients is growing rapidly. Due to the underlying chronic liver disease, patients with NASH often require different approaches to the assessment and management of suspected DILI compared to patients with healthy livers. However, until now, no regulatory guidelines or position papers systematically addressed best practices pertaining to DILI in NASH clinical trials. To address this critical gap, the IQ DILI Initiative developed this consensus paper in collaboration with DILI experts from academia and FDA. The paper focuses on recommended best practices concerning the detection, monitoring, diagnosis and management of suspected acute DILI during clinical trials in patients with NASH to support safer, more effective trials in this increasingly prevalent disease.