Comparative Study on Risk Assessment Tools for Clinical Trials in England, Germany and France
10.12026/j.issn.1001-8565.2023.04.13
- VernacularTitle:英、德、法三国临床试验风险评估工具的比较研究
- Author:
Siyuan XI
1
;
Aiyi ZHANG
2
;
Yin MA
3
;
Jun HE
1
;
Zheng AN
4
;
Zhongguang YU
4
,
5
Author Information
1. Department of Pharmacy, China-Japan Friendship Hospital, Beijing 100029, China
2. Faculty of Biomedicine, Beijing City University, Beijing 100094, China
3. Beijing Ditan Hospital Shunyi Branch, Beijing 101399, China
4. Center for Respiratory, China-Japan Friendship Hospital, Beijing 100029, China
5. School of Economics and Management, Wuhan University, Wuhan 430072, China
- Publication Type:Journal Article
- Keywords:
Clinical Trial;
Risk Assessment Tools;
Risk Management;
Comparative Study
- From:
Chinese Medical Ethics
2023;36(4):434-437
- CountryChina
- Language:Chinese
-
Abstract:
Risk assessment of clinical trials is of great significance to improve the quality of clinical trials. Through systematic comparative analysis of risk assessment tools for clinical trials in Britain, Germany and France, this paper found that the three countries’ risk assessment tools were consistent in terms of legal system guarantee and assessment process, but there were obvious differences in the basic risk classification and risk grading standards of clinical trials. Based on the experience of Britain, France and Germany, this paper proposed to improve the relevant regulations and documents of clinical trial risk management in China from the perspective of Chinese national conditions, further explore the factors affecting clinical trial risk, and develop and design clinical trial risk assessment tools with different discipline characteristics according to the specialties of the discipline to improve the quality and level of clinical trials.
