Sequential Probability Ratio Analysis in Post-market Drug Safety Surveillance

Abstract

Abstract: Objective To review currently used sequential probability ratio analysis methods in medical product safety surveillance. Methods The principles of continuous and group sequential probability ratio analysis methods were reviewed. The key features of these two kinds of sequential methods were compared, and the application status was summarized. Meanwhile, we discussed the areas needed further development. Results The use of sequential probability ratio analysis for post-market drug safety surveillance was quickly emerging. Continuous sequential methods were the preferred approach, but group sequential methods were also promising. ConclusionSequential probability ratio analysis is a feasible method to monitor the drug safety in real time, but methodological development is needed to improve success.

Key words: sequential probability ratio test, adverse drug reaction, near real-time surveillance

CLC Number:

R994.11

ZHANG Xin-ji, GUO Xiao-jing, YE Xiao-fei, PENG Xu-jiao, HE Jia. Sequential Probability Ratio Analysis in Post-market Drug Safety Surveillance[J]. Chinese Journal of Pharmacovigilance, 2018, 15(4): 221-225.

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