Early detection of pharmacovigilance signals with automated methods based on false discovery rates: A comparative study

Drug Safety

Volumn 35, Issue 6, 2012, Pages 495-506

  Ahmed, Ismal ^a,b,c   Thiessard, Frantz ^d,e   Miremont Salam, Ghada ^e,f   Haramburu, Franoise ^e,f   Kreft Jais, Carmen ^g   Bgaud, Bernard ^d,f   Tubert Bitter, Pascale ^a,b  

^a CENTRE FOR RESEARCH IN EPIDEMIOLOGY AND POPULATION HEALTH   (France)

^b UNIVERSITÉ PARIS SACLAY   (France)

^c IMPERIAL COLLEGE LONDON   (United Kingdom)

^d UNIVERSITÉ DE BORDEAUX   (France)

^e BORDEAUX UNIVERSITY HOSPITAL   (France)

^f INSERM   (France)

^g AFSSAPS   (France)

Author keywords

Adverse drug reactions; Bayesian analysis; European Medicines Agency; Pharmacovigilance

Indexed keywords

ARTICLE; AUTOANALYSIS; AUTOMATION; COMPARATIVE STUDY; CONTROLLED STUDY; DATA BASE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FRANCE; NULL HYPOTHESIS; PRIORITY JOURNAL; PROBABILITY; QUANTITATIVE ANALYSIS; RETROSPECTIVE STUDY; SEQUENTIAL ANALYSIS; SIGNAL DETECTION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; DATABASES, FACTUAL; FALSE POSITIVE REACTIONS; FRANCE; HUMANS; MODELS, STATISTICAL; PATTERN RECOGNITION, AUTOMATED; PHARMACEUTICAL PREPARATIONS; PHARMACOVIGILANCE; RETROSPECTIVE STUDIES; TIME FACTORS;

EID: 84861392850     PISSN: 01145916     EISSN: 11791942     Source Type: Journal    
DOI: 10.2165/11597180-000000000-00000     Document Type: Article

References (27)

1. van Puijenbroek EP, Bate A, Leufkens HGM, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf 2002 Feb; 11 (1): 3-10 (Pubitemid 34269590)
2. Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf 2001 Nov; 10 (6): 483-6 (Pubitemid 34100774)
3. Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 1998 Jun; 54 (4): 315-21 (Pubitemid 28328016)
4. Nore GN, Bate A, Orre R, et al. Extending the methods used to screen the WHO drug safety database towards analysis of complex associations and improved accuracy for rare events. Stat Med 2006 Nov 15; 25 (21): 3740-57 (Pubitemid 44613906)
5. Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database. Drug Saf 2002; 25 (6): 381-92 (Pubitemid 34729136)
6. DuMouchel W. Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system. Am Stat 1999 Aug; 53 (3): 177-90
7. DuMouchel W, Pregibon D. Empirical bayes screening for multi-item associations. In: Proceedings of the Seventh ACM SIGKDD International Conference on Knowledge Discovery and Data Mining. San Francisco (CA): ACM, 2001: 67-76 [online].Available from URL: http://portal. acm.org/citation.cfm?id=502526 [Accessed 2010 Mar 26]
8. Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Stat Soc Series B Stat Methodol 1995; 57 (1): 289-300
9. Ahmed I, Dalmasso C, Haramburu F, et al. False discovery rate estimation for frequentist pharmacovigilance signal detection methods. Biometrics 2010 Mar; 66 (1): 301-9
10. Ahmed I, Haramburu F, Fourrier-Relat A, et al. Bayesian pharmacovigilance signal detection methods revisited in a multiple comparison setting. Stat Med 2009 Jun 15; 28 (13): 1774-92
11. Ahmed I, Thiessard F, Miremont-SalameG, et al. Pharmacovigilance data mining with methods based on false discovery rates: a comparative simulation study. Clin Pharmacol Ther 2010 Oct; 88 (4): 492-8
12. Roux E, Thiessard F, Fourrier A, et al. Evaluation of statistical association measures for the automatic signal generation in pharmacovigilance. IEEE Trans Inf Technol Biomed 2005 Dec; 9 (4): 518-27 (Pubitemid 43009859)
13. Matsushita Y, Kuroda Y, Niwa S, et al. Criteria revision and performance comparison of three methods of signal detection applied to the spontaneous reporting database of a pharmaceutical manufacturer. Drug Saf 2007; 30 (8): 715-26 (Pubitemid 47295831)
14. Almenoff JS, LaCroix KK, Yuen NA, et al. Comparative performance of two quantitative safety signalling methods: implications for use in a pharmacovigilance department. Drug Saf 2006; 29 (10): 875-87 (Pubitemid 44511588)
15. Lehman HP, Chen J, Gould AL, et al. An evaluation of computer-aided disproportionality analysis for post-marketing signal detection. Clin Pharmacol Ther 2007 Aug; 82 (2): 173-80 (Pubitemid 47075337)
16. Lindquist M, Stahl M, Bate A, et al. A retrospective evaluation of a data mining approach to aid finding new adverse drug reaction signals in the WHO international database. Drug Saf 2000 Dec; 23 (6): 533-42 (Pubitemid 32001514)
17. Hauben M, Madigan D, Gerrits CM, et al. The role of data mining in pharmacovigilance. Expert Opin Drug Saf 2005 Sep; 4 (5): 929-48 (Pubitemid 41246142)
18. Hochberg AM, HaubenM, Pearson RK, et al. An evaluation of three signal-detection algorithms using a highly inclusive reference event database. Drug Saf 2009; 32 (6): 509-25
19. Hochberg AM, Hauben M. Time-to-signal comparison for drug safety data-mining algorithms vs. traditional signaling criteria. Clin Pharmacol Ther 2009 Jun; 85 (6): 600-6
20. Alvarez Y, Hidalgo A, Maignen F, et al. Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling. Drug Saf 2010 Jun 1; 33 (6): 475-87
21. Thiessard F. Deection des effets indeirables des meicaments par un système de geeation automatise du signal adapteà la base nationale de pharmacovigilance [in French; thesis]. Bordeaux: Universite Victor Segalen Bordeaux 2, 2004
22. Thiessard F, Roux E, Miremont-SalameG, et al. Trends in spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986-2001). Drug Saf 2005; 28 (8): 731-40 (Pubitemid 41132459)
23. Miller GC, Britt H. A new drug classification for computer systems: the ATC extension code. Int J Biomed Comput 1995 Oct; 40 (2): 121-4 (Pubitemid 26019935)
24. Brown EG, Wood L, Wood S. The medical dictionary for regulatory activities (MedDRA). Drug Saf 1999 Feb; 20 (2): 109-17 (Pubitemid 29101275)
25. Ahmed I, Poncet A. PhViD: an R package for pharmacovigilance signal detection [online]. Available from URL: http://cran.r-project.org/web/packages/ PhViD/index.html [Accessed 2012 Mar 29]
26. R Development Core Team. R: a language and environment for statistical computing [online]. Vienna, 2011. Available from URL: http://www.R-project.org [Accessed 2012 Mar 29]
27. Beaud B, Evreux JC, Jouglard J, et al. Imputation of the unexpected or toxic effects of drugs: actualization of the method used in France. Therapie 1985 Apr; 40 (2): 111-8