Analysis and standardization strategies of serious adverse event reports in pediatric drug clinical trials

GUO Chun-yan; ZHANG Yi; YANG Yu-xin; LIANG Yu-guang; DING Qian; WANG Qian; ZHANG Meng; SONG Li-juan; ZHANG Cheng-yue; SUN Yu; GUO Peng

doi:10.20251/j.cnki.1003-3734.2026.07.007

Abstract：Objective:To analyze the issues in the reporting of serious adverse events(SAEs)in pediatric drug clinical trials,propose standardized reporting strategies,ensure the safety and legitimate rights and interests of pediatric research participants,and improve the pharmacovigilance system for pediatric clinical trials.Methods:An analysis was conducted on 136 SAEs reported to the medical ethics committee of our hospital from our hospital between January 1,2015 and April 30,2025.The analysis covered the gender and age of affected children,medical specialities involved,types of drugs,patterns of SAE occurrence,causal relationship with the study drug,reporting issues,and whether they were judged as suspected unexpected serious adverse reactions(SUSARs).Results:Among the 136 SAEs,the pediatric hematology specialty had the highest number of cases(35 cases);the number of male cases(77 cases)was higher than that of female cases(59 cases),and most occurred during childhood(86 cases);among the drug types,therapeutic biological products had the highest number of cases(76 cases);the most significant impact on research participants was the requirement for hospitalization(124 cases);the number of cases where SAEs were"definitely unrelated"to the trial drug was the highest(47 cases),and the most significant impact on clinical trials was"no change in dose,continue medication"(76 cases);13 cases were judged as SUSARs.Conclusion:It is necessary to establish a standardized reporting and handling system for SAEs in pediatric drug clinical trials,to develop SAE reporting forms suitable for children,and to attach great importance to the assessment of children's specific conditions.Sponsors,researchers,and ethics committees must fully understand the differences in SAE spectra between children and adults,strengthen safety monitoring,and maximize the protection of the rights and safety of pediatric subjects.