A Likelihood Ratio Test Based Method for Signal Detection With Application to FDA’s Drug Safety Data
基于似然比检验的信号检测及其 FDA 药物安全数据应用
Several statistical methods that are available in the literature to analyze postmarket safety databases, such as the U.S. Federal Drug Administration’s (FDA) adverse event reporting system (AERS), for identifying drug-event combinations with disproportionately high frequencies, are subject to high false discovery rates. Here, we propose a likelihood ratio test (LRT) based method and show, via an extensive simulation study, that the proposed method while retaining good power…