Adoption of Artificial Intelligence in drug clinical trial management under the Good Clinical Practice framework and strategy for optimization
10.3760/cma.j.cn113565-20241115-00301
- VernacularTitle:GCP框架下人工智能辅助药物临床试验管理与优化策略研究
- Author:
Wencan ZHOU
1
;
Lihong LIU
1
;
Xiangyu ZHAO
1
Author Information
1. 北京大学人民医院，北京 100032
- Publication Type:Journal Article
- Keywords:
Artificial Intelligence;
Drug clinical trials;
Good Clinical Practice;
AI-assisted management;
Optimization strategy
- From:
Chinese Journal of Medical Science Research Management
2025;38(2):100-107
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To systematically review the application of Artificial Intelligence (AI) in drug clinical trial management under the Good Clinical Practice (GCP) framework, identify current gaps and shortcomings, and to propose an optimization strategy.Methods:Main academic databases were searched for literature published in Chinese and English between September 2019 and September 2024. Relevant studies were included. Key findings were extracted and summarized.Results:AI applications had been extensively explored and reported in areas such as informed consenting and protection of human subject rights, trial design and implementation, subject screening and recruitment, data processing and management, and reporting. Current literature was predominantly international. Despite a foundation of applied research, issues existed such as lack of standardization, fragmented tools, and insufficient interconnectivity and interoperability.Conclusions:China has marked potential to adopt and integrate AI technologies in drug clinical trial management under the GCP framework. Future efforts should focus on establishing standards, covering end-to-end processes, promoting multi-tool collaboration and data interconnectivity, and building robust data security and ethical protection mechanisms in an AI environment. Seizing the opportunities can enhance drug clinical trial management.
