References
Bate A, Lindquist M, Edwards IR, et al. A Bayesian neural network method for adverse drug reaction signal generation. Eur J Clin Pharmacol 1998; 54(4): 315–21
Almenoff J, Tonning JM, Gould AL, et al. Perspectives on the use of data mining in pharmacovigilance. Drug Saf 2005; 28(11): 981–1007
European Medicines Agency, EudraVigilance Expert Working Group. Guideline on the use of statistical signal detection methods in the EudraVigilance data analysis system [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/phvwp/10646406en.pdf [Accessed 2010 May 5]
CIOMS Working Group VIII. Report on practical aspects of signal detection in pharmacovigilance. Geneva: CIOMS. In press
Norén GN, Orre R, Bate A, et al. Duplicate detection in adverse drug reaction surveillance. Data Min Knowl Discov 2007; 14: 305–28
Hauben M, Reich L, DeMicco J, et al. Extreme duplication in the US FDA Adverse Events Reporting System database. Drug Saf 2007; 30(6): 551–4
Henegar C, Bousquet C, Lillo-Le Louët A, et al. Building an ontology of adverse drug reactions for automated signal generation in pharmacovigilance. Comput Biol Med 2006; 36(7–8): 748–67
Brown EG. Effects of coding dictionary on signal generation: a consideration of use of MedDRA compared with WHO-ART. Drug Saf 2002; 25(6): 445–52
Hauben M, Aronson JK. Defining ‘signal’ and its subtypes in pharmacovigilance based on a systematic review of previous definitions. Drug Saf 2009; 32(2): 99–110
Meyboom RH, Lindquist M, Egberts AC, et al. Signal selection and follow-up in pharmacovigilance. Drug Saf 2002; 25(6): 459–65
Erratum. Br J Clin Pharmacol 2007; 64 (1): 118
Lindquist M, Ståhl 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; 23(6): 533–42
Hochberg AM, Hauben M, 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
Bailey S, Singh A, Azadian R, et al. Prospective data mining of six products in the US FDA Adverse Event Reporting System: disposition of events identified and impact on product safety profiles. Drug Saf 2010; 33(2): 139–46
Alvarez Y, Hidalgo A, Maignen F, et al. Validation of statistical signal detection procedures in EudraVigilance post-authorisation data: a retrospective evaluation of the potential for earlier signalling. Drug Saf 2010; 33(6): 475–87
Ståhl M, Lindquist M, Edwards IR, et al. Introducing triage logic as a new strategy for the detection of signals in the WHO Drug Monitoring Database. Pharmacoepidemiol Drug Saf 2004; 13(6): 355–63
Levitan B, Yee CL, Russo L, et al. A model for decision support in signal triage. Drug Saf 2008; 31(9): 727–35
Walker AM. Orthogonal predictions: follow-up questions for suggestive data. Pharmacoepidemiol Drug Saf 2010; 19(5): 529–32
Hauben M, Reich L, Gerrits CM, et al. Illusions of objectivity and a recommendation for reporting data mining results. Eur J Clin Pharmacol 2007; 63(5): 517–21
Hauben M, Bate A. Data mining in drug safety: side effects of drugs essay. In: Aronson JK, editor. Side effects of drugs annual. Vol. 29. Amsterdam: Elsevier, 2007: xxxiii–xlvi
Taubes G. Epidemiology faces its limits. Science 1995; 269(5221): 164–9
Meyboom RH, Hekster YA, Egberts AC, et al. Causal or casual? The role of causality assessment in pharmacovigilance. Drug Saf 1997; 17(6): 374–89
Aronson JK, Hauben M. Anecdotes that provide definitive evidence. BMJ 2006; 333(7581): 1267–9
Hauben M, Reich L. Response to letter by Levine et al. Br J Clin Pharmacol 2006; 61(1): 115–7
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
Hochberg AM, Hauben M. Time-to-signal comparison for drug safety data-mining algorithms vs. traditional signaling criteria. Clin Pharmacol Ther 2009; 85(6): 600–6
Bate A, Edwards IR. Data mining in spontaneous reports. Basic Clin Pharmacol Toxicol 2006; 98(3): 324–30
Acknowledgements
No sources of funding were used in the preparation of this editorial. Manfred Hauben is a full-time employee of Pfizer Inc., and owns stock/stock options in Pfizer Inc. and other pharmaceutical companies. Niklas Norén has no conflicts of interest to declare.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Haubenand, M., Norén, G.N. A Decade of Data Mining and Still Counting. Drug-Safety 33, 527–534 (2010). https://doi.org/10.2165/11532430-000000000-00000
Published:
Issue Date:
DOI: https://doi.org/10.2165/11532430-000000000-00000