Multidimensional analysis and scientific prospect of expected value setting for signal detection by vaccine marketing authorization holders
10.13200/j.cnki.cjb.004649
- VernacularTitle:疫苗上市许可持有人信号检测预期值设定的多维剖析与科学展望
- Author:
Yan DENG
1
Author Information
1. Department of Pharmacovigilance, Institute of Medical Biology, Chinese Academy of Medical Sciences & Peking Union Medical College, Kunming 650118, Yunnan Province, China
- Publication Type:Journal Article
- Keywords:
Vaccine;
Marketing authorization holders;
Signal detection;
Expected value setting;
Clinical trial;
Real world;
Artificial intelligence
- From:
Chinese Journal of Biologicals
2026;39(02):251-256
- CountryChina
- Language:Chinese
-
Abstract:
In order to effectively ensure the effectiveness and scientific nature of vaccine safety monitoring, it is necessary to deeply explore the reference data sources, key elements to be considered and future development trends that vaccine marketing authorization holders rely on to set signal detection expected values in pharmacovigilance. By systematically sorting out various data types for reference in expected value setting, multiple elements that affect expected value setting can be deeply analyzed, the dimensions and methods of considering these data and elements during the setting process can be explored, and the future development direction of expected value setting can be analyzed. The setting of expected values of signal detection requires a comprehensive consideration of various data and elements, keep up with the forefront of technological development, and flexibly apply advanced technologies, so as to achieve precision, personalization and dynamism in expected value setting and ensure vaccine safety. This paper clarifies the advantages and disadvantages of clinical trial data,real-world usage data and data of similar products as reference for expected value setting, expounds the effects of differences in factors such as vaccine and vaccination population characteristics, monitoring system characteristics, policy and environmental characteristics on the setting of expected values, and puts forward the deve-lopment trends of expected value setting in the future.
