Research on Influencing Factors of Drug Clinical Trial Risks in China Based on Literature Analysis
10.12026/j.issn.1001-8565.2023.06.04
- VernacularTitle:基于文献分析的我国药物临床试验风险影响因素研究
- Author:
Aiyi ZHANG
1
;
Siyuan XI
2
;
Zheng AN
3
;
Zhongguang YU
3
,
4
Author Information
1. Department of Biomedicine, Beijing City University, Beijing 100094, China
2. Department of Pharmacy, China-Japan Friendship Hospital, Beijing 100029, China
3. Center of Respiratory, China-Japan Friendship Hospital, Beijing 100029, China
4. School of Economics and Management, Wuhan University, Wuhan 430072, China
- Publication Type:Journal Article
- Keywords:
Drug Clinical Trials;
Risk Identification;
Risk Management;
Literature Analysis
- From:
Chinese Medical Ethics
2023;36(6):613-617
- CountryChina
- Language:Chinese
-
Abstract:
【Objective:】 To sort out the influencing factors of drug clinical trial risks and improve the risk management level of drug clinical trials in China. 【Methods:】 The literature analysis method was used to sort out the literature related to the risk management of drug clinical trials in China, and the text analysis method was used to summarize and refine the influencing factors of drug clinical trial risks. 【Results:】 The risk categories of drug clinical trials were divided into 5 parts, namely drug clinical trial institution management, ethics committee management, clinical trial designs, researchers, and subjects, involving 13 main risk influencing factors and 21 specific risk points. 【Conclusion:】 By strengthening the construction of drug clinical trial institutions and ethical management capabilities, optimizing research protocol design, enhancing researchers’ awareness and ability, and establishing a subject management system to improve the quality of drug clinical trials.
