Analysis on Protocol Violation in Pediatric Clinical Trials and Its Countermeasures
10.12026/j.issn.1001-8565.2023.08.04
- VernacularTitle:儿科临床试验违背方案分析及应对措施
- Author:
Ji LI
1
;
Linyan QI
1
;
Jianhua MAO
1
;
Shaoqing NI
1
Author Information
1. Clinical Trial Institution/National Clinical Research Center for Child Health, Children’s Hospital of Zhejiang University School of Medicine, Hangzhou 310052, China
- Publication Type:Journal Article
- Keywords:
Pediatric Clinical Trials;
Pediatric Research Participants;
Pediatric Research Participants Protection;
Ethics Committees;
Protocol Violation
- From:
Chinese Medical Ethics
2023;36(8):847-852
- CountryChina
- Language:Chinese
-
Abstract:
By collecting 475 protocol violation reports of pediatric clinical trials accepted by the ethics committee of a grade A tertiary hospital from January 2016 to December 2022, and conducting classification statistics of the responsible body, types of violation, and natures of violation, this paper analyzed and discussed the specific reasons and response measures for protocol violation. The results showed that the most common types of protocol violation included missed medication and incorrect medication dosage for pediatric research participants, missed laboratory inspection, over-windowed follow-up, and non-compliance with inclusion/exclusion criteria. And the responsibility bodies were pediatric research participants and/or their guardians, followed by the researchers. Besides, the sponsor, clinical trial coordinator, and other factors also contributed to protocol violation. Establishing awareness of responsible body, emphasizing subject management, building sound quality control system, and strengthening ethical supervision are the main countermeasures to prevent and reduce protocol violation in pediatric clinical trials, which helps to protect the safety and rights of pediatric research participants and promote standardized research in pediatric clinical trials.
