Management and practice of ethical review for “amendment” in drug clinical trials
10.12026/j.issn.1001-8565.2026.01.08
- VernacularTitle:药物临床试验“修正案”伦理审查的管理与实践
- Author:
Xingyi LI
1
;
Zhonglin CHEN
1
;
Xingchi QU
2
;
Yu FENG
1
;
Huihui HAN
1
Author Information
1. Ethics Office， Shanghai Chest Hospital/the Affiliated Chest Hospital， Shanghai Jiao Tong University School of Medicine， Shanghai 200030， China
2. Bestudy 〈Shanghai〉 Medical Technology Company Limited， Shanghai 200083， China
- Publication Type:Journal Article
- Keywords:
drug clinical trial;
ethical review;
amendment
- From:
Chinese Medical Ethics
2026;39(1):58-63
- CountryChina
- Language:Chinese
-
Abstract:
Driven by the growing practical need to accelerate drug development and the continuous innovation of trial design in recent years， the number of protocol amendments during clinical trials have gradually increased， and the changed contents have become more flexible and complex， which significantly heightens the difficulty of ethical review on amendments. Against this backdrop， it is of great importance to fully leverage the role and responsibilities of ethics committees， effectively control clinical trial risks， and ensure subject safety. This paper analyzed development trends of protocol amendments in recent years， sorted out requirements for protocol amendments in Chinese regulations and guiding principles， and examined difficulties of amendment ethical review in practical work. Based on these， targeted strategies and recommendations were proposed， namely， strengthening the integration with scientific review， enhancing the formal review， adjusting the scope of review according to approval notifications， and adopting appropriate review methods， with a view to providing insights and references for the management of the amendment ethical review in drug clinical trials.
