Investigation and analysis on research design problems in adverse drug reaction signal detection study in China
10.3760/cma.j.cn114015-20220801-00693
- VernacularTitle:国内药物不良反应信号检测文献研究设计问题的调查和分析
- Author:
Rui DAI
1
;
Qingxia ZHANG
;
Yang HU
;
Huanling WANG
;
Bin ZHAO
Author Information
1. 中国医学科学院北京协和医学院北京协和医院药剂科，北京 100730
- Publication Type:Journal Article
- Keywords:
Pharmacovigilance;
Drug-related side effects and adverse reaction;
Adverse drug reaction reporting systems;
Signal detection;
Evaluation studies;
Research
- From:
Adverse Drug Reactions Journal
2023;25(8):475-481
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To understand the current situation and problems of research design in adverse drug reaction (ADR) signal detection study in China.Methods:The literature on ADR signal detection study in SinoMed, CNKI, WanFang Data and VIP databases were retrieved (up to May 30, 2022). The research purpose, research direction (target drug, target ADR), source database of signals, target drug role, reference drug, signal detection algorithm, and bias control of the literature were analyzed descriptively one by one.Results:A total of 165 articles were included, of which 146 (88.5%) were published in core journals. From 2013 to 2022 (January to May, 2022), there were 4, 3, 2, 7, 8, 11, 20, 29, 55, and 26 relevant articles, respectively. Problems in these studies were as follows: research purposes were not clear in 6.7% (11/165) of the literature; target ADRs were selected as non targeted in 80.6% (133/165) of the literature; the domestic database was less utilized [only 9.7% (16/165)]; did the selection range of the target drug role were not mentioned in 33.9% (56/165) of the literature; only a single algorithm for signal detection was used in 36.4% (60/165) of the literature; bias analysis was not conducted in 85.5% (141/165) of the literature.Conclusions:The domestic literature on ADR signal detection has problems of poor standardization in research design, such as unclear research purpose and direction, incomplete research items, etc. Chinese scholars should further improve the quality of research design while strengthening the research on ADR signal detection.
