LI Chunxiao, LING Xiao, LI Xuelin, et al. Discussion on the Study on Comprehensive Evaluation of the Safety of Post-Marketing Chinese Patent Medicines[J]. Journal of Traditional Chinese Medicine2020, 61(12): 1049-1053.
LI Chunxiao, LING Xiao, LI Xuelin, et al. Discussion on the Study on Comprehensive Evaluation of the Safety of Post-Marketing Chinese Patent Medicines[J]. Journal of Traditional Chinese Medicine2020, 61(12): 1049-1053.DOI: 10.13288/j.11-2166/r.2020.12.008.
Post-marketing safety re-evaluation research usually finds adverse drug reactions(ADR) through passive monitoring
active monitoring
or meta-analysis of the spontaneous reporting system
and re-evaluates was performed based on them. Therefore
post-marketing drug safety research is a systematic and dynamic project. It is difficult to form a drug clinical safety conclusion through a single research paradigm. It is necessary to integrate multiple methods to conduct an objective and comprehensive evaluation. Due to the different data types obtained by various quantitative research methods and qualitative research results
it is difficult to integrate various single results to form a comprehensive result. Mixed methods research(MMR) is a supplement to qualitative research and quantitative research. It can achieve a strong combination of the two research methods. This research model is highly consistent with the characteristics and needs of post-marketing safety reassessment. Therefore
MMR design can be used to integrate quantitative data and qualitative data
and explore ways to build a comprehensive evaluation of the safety of Chinese patent medicines after they are marketed.