Drug-induced liver injury (DILI) poses a significant challenge in oncology drug development and clinical practice. Recognizing the complexities of monitoring cancer patients, who may have pre-existing liver conditions or be at risk due to treatments, hepatic metastases, or concomitant medications, a consensus has been reached by experts to provide guidance on DILI management in oncology clinical trials.
The recommendations, published by the IQ Consortium DILI Initiative in collaboration with academic and regulatory experts, address the need for standardized best practices in DILI detection, assessment, and management within the oncology setting. The consensus is based on extensive literature review and expert interpretation.
The guidance includes recommendations for patient eligibility in clinical trials, both with and without pre-existing liver involvement. It also specifies changes in liver function tests that should trigger increased monitoring or discontinuation of the study drug. Detailed advice is provided on causality assessment for suspected DILI events, as well as strategies for rechallenge and dose modification.
"This review brings together evidence-based recommendations and expert opinion to provide the first dedicated consensus for best practices in detection, assessment, and management of DILI in oncology clinical trials," the authors stated. The recommendations aim to improve patient safety and optimize drug development in oncology by providing a clear framework for managing DILI risks.
