Bias and control in the monitoring and evaluation of post-marketing drug using the medical big data

doi:10.19803/j.1672-8629.2022.03.02

Abstract

Abstract: Objective To introduce the current situation, existing bias and possible control methods of post-marketing drug monitoring and evaluation research based on medical big databases at home and abroad, suggesting references for drug risk monitoring and management in China. Methods The specific practices of post-marketing drug monitoring and evaluation based on medical big data in the developed countries were systematically summarized, and the gaps in China were analyzed. The bias and control in research design, data collection, and statistical analysis were evaluated. In addition, the opportunities and challenges facing our country at present were assessed. Results and Conclusion The developed countries have established efficient and sustainable post-marketing monitoring and vigilance systems based on medical big data. Full consideration and control of potential bias in study design, implementation, and statistical analysis are necessary to determine the causal relationship between drugs and adverse reactions. We should learn from European and American advanced experience, improve and integrate existing medical big data, and carry out research on pharmacoepidemiology.

Key words: medical big data, post-marketing, monitoring, selection bias, information bias, confounding, pharmacoepidemiology

CLC Number:

R969.3

WANG Li, WANG Xiaomo, YANG Chenlu. Bias and control in the monitoring and evaluation of post-marketing drug using the medical big data[J]. Chinese Journal of Pharmacovigilance, 2022, 19(3): 239-243.

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