Ethical review and management of serious adverse events in anti-tumor drug clinical trials
10.3760/cma.j.cn113565-20220902-00177
- VernacularTitle:抗肿瘤药物临床试验严重不良事件的伦理审查与管理
- Author:
Lei ZHANG
1
;
Chunyi HAO
;
Jie LI
Author Information
1. 北京大学肿瘤医院医学伦理委员会 100142
- Keywords:
Ethical review;
Management;
Serious adverse event;
Retrospective analysis
- From:
Chinese Journal of Medical Science Research Management
2023;36(2):150-155
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To discuss ethical review and management of serious adverse events in anti-tumor drug clinical trials in a grade A tertiary cancer hospital for timely and effective protection of subjects.Methods:The main contents and ethical management of ethical review on serious adverse events were retrospectively analyzed including the number, distribution rules, and whether they were reported in time in clinical trials conducted in our hospital in 2021.Results:A total of 1 789 serious adverse events in 259 clinical trials were reported, with more male subjects than female, with an average age of 59.95 years, mainly concentrated in the 50~59 age and 60~69 age groups, accounting for 27.45% and 42.37% respectively. Digestive oncology department, thoracic oncology department and renal cancer melanoma department ranked in the top three for the number of clinical trials and reports of serious adverse events. The highest incidence of serious adverse events was hospitalization at 63.44% and the lowest incidence was disability at 0.39%. The highest proportion of serious adverse events possibly related to clinical trials was 35.72%. Expected serious adverse events accounted for 65.85% versus 34.15% unexpected ones, and the difference between different correlations of serious adverse events whether they were expected or not.was statistically significant. Among the measures taken by the investigator for the test drugs due to serious adverse events, drug discontinuation was the most, accounting for 42.54%, while 3.07% of the trial plans modified the study protocol/informed consent. Serious adverse events reported within 24 hours accounted for 87.20%, and those reported in 24 hours and beyond accounting for 12.80%. A statistically significant difference of the reporting time between the registered and investigator initiated clinical trials was observed.Conclusions:The ethics committee should attach importance to ethical review and management of serious adverse events, pay attention to whether they were reported timely and accurately, strengthen supervision, and effectively protect the safety and interests of the subjects.
