Application and prospect of real world study in clinical efficacy and safety evaluation of generic drugs
10.3760/cma.j.cn114015-20230103-01203
- VernacularTitle:真实世界研究在国产仿制药临床疗效与安全性评价中的应用及展望
- Author:
Lan ZHANG
1
;
Xianzhe DONG
1
;
Zhizhou WANG
1
Author Information
1. 首都医科大学宣武医院药学部，北京 100053
- Publication Type:Journal Article
- Keywords:
Comparative study;
Controlled clinical trial;
Safety;
Real world study;
Generic drugs;
Volume-based procurement;
Clinical efficacy
- From:
Adverse Drug Reactions Journal
2023;25(3):129-132
- CountryChina
- Language:Chinese
-
Abstract:
It was a very common phenomenon that an original drug was replaced by a generic drug after its patent expires. In order to further verify the efficacy and safety of domestic generic drugs selected in the national centralized volume-based procurement, the National Healthcare Security Administration guided a number of medical institutions to carry out large-scale real-world studies on clinical efficacy and safety of generic drugs, involving drugs for treating cardiovascular and cerebrovascular diseases, neuropsychiatric diseases, chronic hepatitis B, and tumor, and anesthetics. More than 110 thousands patients were included in the study. Evidence from real world studies and randomized controlled trials can complement each other. Because of the diversity of data, the complexity of design, the high requirements of analytical methods, and the uncertainty of the interpretation of results in the real world studies, higher requirements for the safety and efficacy evaluation and regulatory decision-making of generic drugs are put forward. Possible recommendations to constantly promote the scientificalness and standardization of the production and use of real world evidence are as follows: further strengthen the informatization construction in medical institutions and promote the standardization and convenience in real world data use, improve the scientificalness of research design and data processing, explore and improve the real world evidence quality evaluation criteria, strengthen the awareness of data security and pay attention to the participants' privacy protection, etc.
