Spontaneous Reporting System Modelling for the Evaluation of Automatic Signal Generation Methods in Pharmacovigilance

Pharmacovigilance aims at detecting adverse effects of marketed drugs. It is generally based on a Spontaneous Reporting System (SRS) that consists of the spontaneous reporting, by health professionals, of events that are supposed to be adverse effects of marketed drugs. SRS supply huge databases, the human-based exploitation of which cannot be exhaustive. Automated signal generation methods have been proposed in the literature but no consensus exists concerning their efficiency and applicability due to the difficulties in evaluating the methods on real data.

[1]  M. Lindquist,et al.  A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions , 2002, Pharmacoepidemiology and drug safety.

[2]  William DuMouchel,et al.  Empirical bayes screening for multi-item associations , 2001, KDD '01.

[3]  F. Haramburu,et al.  Spontaneous reporting of adverse drug reactions: who reports and what? , 1998, Pharmacoepidemiology and drug safety.

[4]  Stephen Evans.  Sequential probability ratio tests applied to public health problems , 2003 .

[5]  S. Evans,et al.  Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports , 2001, Pharmacoepidemiology and drug safety.

[6]  William DuMouchel,et al.  Bayesian Data Mining in Large Frequency Tables, with an Application to the FDA Spontaneous Reporting System , 1999 .

[7]  Antoine Egberts,et al.  The reporting odds ratio versus the proportional reporting ratio: ‘deuce’ , 2004, Pharmacoepidemiology and Drug Safety.

[8]  Constantin V. Negoita,et al.  On Fuzzy Systems , 1978 .

[9]  R. Meyboom,et al.  Use of Measures of Disproportionality in Pharmacovigilance , 2002, Drug safety.

[10]  E. Puijenbroek,et al.  Application of Quantitative Signal Detection in the Dutch Spontaneous Reporting System for Adverse Drug Reactions , 2003, Drug safety.

[11]  Bernadette Bouchon-Meunier,et al.  Logique floue : principes, aide à la décision , 2003 .

[12]  Bernadette Bouchon-Meunier,et al.  Méthodes de raisonnement , 2003 .

[13]  J Lellouch,et al.  Power and weakness of spontaneous reporting: a probabilistic approach. , 1992, Journal of clinical epidemiology.

[14]  A Lawrence Gould,et al.  Practical pharmacovigilance analysis strategies. , 2003, Pharmacoepidemiology and drug safety.

[15]  A. Bate,et al.  A Bayesian neural network method for adverse drug reaction signal generation , 1998, European Journal of Clinical Pharmacology.

[16]  Kenneth J Rothman,et al.  The reporting odds ratio and its advantages over the proportional reporting ratio , 2004, Pharmacoepidemiology and drug safety.