Application of biclustering algorithm in adverse drug reaction monitoring system of China.

Purpose: Signal evaluation is considered to be a tedious process owing to the large number of disproportional signals detected. This study aimed to apply a biclustering algorithm in the spontaneous reporting system of China and to obtain the optimal parameters. The biclustering algorithm is expected to improve the efficiency of signal evaluation by identifying similar signal groups.

Signal Detection Based on Time to Onset Algorithm in Spontaneous Reporting System of China.

Introduction: The method of time-to-onset (TTO) has been proposed to overcome the drawbacks of traditional disproportionality analyses (DPAs), and it has been used for detecting safety signals of vaccines and some non-vaccine products in spontaneous reporting systems (SRSs). However, there is no consensus on its superiority over DPAs. Further, it is still not clear whether this novel approach can be generalized to the entire national SRS database.

National ADR Monitoring System in China.

It has been more than 25 years since an adverse drug reaction (ADR) monitoring agency was first established in China. In the past few years, the National ADR Monitoring System (NADRMS) has developed rapidly in the country. However, this system has not been reviewed in detail in the literature.

Exploration of statistical shrinkage parameters of disproportionality methods in spontaneous reporting system of China.

Purpose: Statistical shrinkage is a potential statistical method to improve the accuracy of signal detection results and avoid spurious associations detected by disproportionality analyses. In this study, we introduced statistical shrinkage influence on disproportionality methods in spontaneous reporting system in China.

Methods: We added the shrinkage parameters in the numerator and denominator, denoted as in the formula of disproportionality analysis.

A comparison of disproportionality analysis methods in national adverse drug reaction databases of China.

Objective: Several disproportionality analysis methods are widely used for signal detection. The goal of this study was to compare the concordance of the performance characteristics of these methods in spontaneous reporting system of China.

Methods: Algorithms including reporting odds ratio (ROR), proportional reporting ratio (PRR) and information component (IC), a composite criterion previously used by Medicines and Healthcare Products Regulatory Agency (MHRA) were compared.