| アブストラクト | A likelihood ratio test, recently developed for the detection of signals of adverse events for a drug of interest in the FDA Adverse Events Reporting System database, is extended to detect signals of adverse events simultaneously for all the drugs in a drug class. The extended likelihood ratio test methods, based on Poisson model (Ext-LRT) and zero-inflated Poisson model (Ext-ZIP-LRT), are discussed and are analytically shown, like the likelihood ratio test method, to control the type-I error and false discovery rate. Simulation studies are performed to evaluate the performance characteristics of Ext-LRT and Ext-ZIP-LRT. The proposed methods are applied to the Gadolinium drug class in FAERS database. An in-house likelihood ratio test tool, incorporating the Ext-LRT methodology, is being developed in the Food and Drug Administration. |
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| ジャーナル名 | Statistical methods in medical research |
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| 投稿日 | 2016/5/5 |
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| 投稿者 | Zhao, Yueqin; Yi, Min; Tiwari, Ram C |
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| 組織名 | 1 Division of Biometrics VII, Office of Biostatistics, MD, USA.;2 Department of Statistics, University of Missouri, Columbia, MO,USA.;3 Office of Biostatistics, MD, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/27142982/ |
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