To characterize clinical features, identify risk factors, and propose risk management strategies for drug-induced liver injury (DILI) in clinical trials.

260 drug-induced liver injury suspected unexpected serious adverse reaction (SUSAR) reports were systematically extracted from China’s National Medical Products Administration Pharmacovigilance System in Clinical Trials (January 2020-February 2025).

Key risk profiles included anticancer drug trials (86.92%), combination therapies (48.85%), elderly participants (≥50 years, 76.89%), phase Ⅲ studies (45.00%). Hospitalization/prolonged hospitalization occurred in 75.00% of cases. Sponsor-investigator causality assessments showed 91.54% concordance. Outcomes remained unresolved in 44.62% of cases, while permanent treatment discontinuation was the least frequent intervention (8.08%).

Implementation of early-warning systems, dynamic liver monitoring, standardized causality assessment, and personalized risk control should be enforced in clinical trial safety information risk management.