Exploration of the Method of Developing Core Data Sets for Post-marketing Clinical Safety Evaluation of Chinese Proprietary Medicine
- VernacularTitle:中成药上市后临床安全性评价核心数据集的构建方法探索
- Author:
Ruijin QIU
1
;
Min LI
;
Jiayuan HU
;
Ya HUANG
;
Tianmai HE
;
Songjie HAN
;
Rui ZHENG
;
Xiaoyu ZHANG
;
Manke GUAN
;
Jing CHEN
;
Hongcai SHANG
Author Information
- Keywords: Chinese proprietary medicine; safety; clinical evaluation; core data set; methodology
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(10):1723-1728
- CountryChina
- Language:Chinese
- Abstract: The insufficient reporting of adverse reactions of Chinese proprietary medicines is common. In addition, there is a lack of safety information in the specifications of Chinese proprietary medicines, which led to less evidence for clinical safety of Chinese proprietary medicines in clinical practice. It is urgent to carry out post-marketing clinical safety re-evaluation of Chinese proprietary medicine. Developing a clinical safety evaluation data set for Chinese proprietary medicine may reduce the insufficient reporting of safety information and the inconsistency of data reporting in similar studies, as well as include more studies in systematic reviews, so that they can provide higher-level evidence for clinical safety of Chinese proprietary medicine. This paper proposes a method for developing core data set of clinical safety evaluation of Chinese proprietary medicine: firstly, the application scope of core data set for clinical safety evaluation was determined according to the characteristics of diseases, population, research objectives, administration methods, evaluation methods, etc. Systematic reviews and semi-structured interviews should be conducted to develop the list of original items for clinical safety evaluation. Based on the list, Delphi surveys can be developed in different stakeholders. Then the final core data set can be developed via consensus meetings.
