Comparison of likelihood ratio tests in post-marketing safety surveillance

doi:10.19803/j.1672-8629.20230132

Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (6): 655-660.
DOI: 10.19803/j.1672-8629.20230132

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Comparison of likelihood ratio tests in post-marketing safety surveillance

PAN Zhemin¹, XU Sheng², ZHENG Yi³, CHEN Chenxin³, LIU Yongmei⁴, ZHANG Pengpeng⁴, YE Xiaofei^3#, HE Jia^1,3,*

¹Tongji University School of Medicine, Shanghai 200092, China;
²BeiGene (Shanghai) Co., Ltd., Shanghai 200040, China;
³Department of Health Statistics, Naval Medical University, Shanghai 200433, China;
⁴Tianjin Rehabilitation Center of Joint Logistic Support Force, Tianjin 300191, China

Received:2022-03-09 Online:2023-06-15 Published:2023-06-15

Abstract

Abstract: Objective To survey and compare likelihood ratio test (LRT) approaches to post-marketing safety surveillance. Methods The fundamentals of likelihood ratio tests as well as the advantages and disadvantages of each method were summarized. Meanwhile, priorities of research in the future were predicted. Results Existing evidence suggested that LRT methods could better control type I errors than the reporting odds ratio and information component methods. Besides, LRT approaches employed a class of precise statistical tools which enabled objective evaluation under various scenarios. Conclusion LRT methods are feasible for post-marketing safety surveillance, especially when rigorous control of the false discovery rate is required or when a trade-off between the false discovery rate/type I error incidence and sensitivity/power is needed. However, there are still some problems that remain unsettled.

Key words: likelihood ratio test, post-marketing safety surveillance, type I error, reporting odds ratio, information component methods

CLC Number:

R911
R994

PAN Zhemin, XU Sheng, ZHENG Yi, CHEN Chenxin, LIU Yongmei, ZHANG Pengpeng, YE Xiaofei, HE Jia. Comparison of likelihood ratio tests in post-marketing safety surveillance[J]. Chinese Journal of Pharmacovigilance, 2023, 20(6): 655-660.

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Comparison of likelihood ratio tests in post-marketing safety surveillance

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