Discussion of the methodology and implementation steps for assessing the causality of adverse event
10.13699/j.cnki.1001-6821.2024.02.031
- VernacularTitle:药物不良事件因果关系评估方法及实施步骤讨论
- Author:
Hong FANG
1
;
Shuo-Peng JIA
;
Hai-Xue WANG
;
Xiao-Jing PEI
;
Min LIU
;
An-Qi YU
;
Ling-Yun ZHOU
;
Fang-Fang SHI
;
Shu-Jie LU
;
Shu-Hang WANG
;
Yue YU
;
Dan-Dan CUI
;
Yu TANG
;
Ning LI
;
Ze-Huai WEN
Author Information
1. 国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院药物临床试验研究中心,北京 100021
- Keywords:
adverse event;
case evaluation;
causality assessment;
evaluation methods;
pharmacovigilance
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(2):299-304
- CountryChina
- Language:Chinese
-
Abstract:
The assessment of adverse drug events is an important basis for clinical safety evaluation and post-marketing risk control of drugs,and its causality assessment is gaining increasing attention.The existing methods for assessing the causal relationship between drugs and the occurrence of adverse reactions can be broadly classified into three categories:global introspective methods,standardized methods,and probabilistic methods.At present,there is no systematic introduction of the operational details of the various methods in the domestic literature.This paper compares representative causality assessment methods in terms of definition and concept,methodological steps,industry evaluation and advantages and disadvantages,clarifies the basic process of determining the causality of adverse drug reactions,and discusses how to further improve the adverse drug reaction monitoring and evaluation system,with a view to providing a reference for drug development and pharmacovigilance work in China.
