A model for decision support in signal triage.

Drug Safety : an International Journal of Medical Toxicology and Drug Experience
Bennett LevitanStephen L Klincewicz

Abstract

Spontaneous reporting of suspected adverse drug reactions (ADRs) has long been a cornerstone of pharmacovigilance. With the increasingly large volume of ADRs, regulatory agencies, scientific/academic organizations and marketing authorization holders have applied statistical tools to assist in signal detection by identifying disproportionate reporting relationships in spontaneous reporting databases. These tools have generated large numbers of signals defined as drug-ADR reporting associations that meet specified statistical criteria. The challenge is to identify which signals are most likely to be medically important and therefore warrant priority for further investigation. Decisions related to signal triage are often complex and are based on a combination of clinical, epidemiological, pharmacological and regulatory criteria. There are no specific regulations, guidelines or standards that provide an objective basis for these decisions. This paper describes preliminary work to identify and quantify the specific factors that contribute to a decision to prioritize a specific drug-ADR combination for further in-depth review. We applied a tool from the discipline of decision analysis to systematically assess the important attributes...Continue Reading

References

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Jun 20, 2002·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ana SzarfmanRobert T O'Neill
Jun 20, 2002·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Patrick Purcell, Simon Barty
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Sep 27, 2005·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Patrick WallerJane Moseley
Sep 27, 2005·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Emma HeeleyJane Moseley
Oct 20, 2005·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·June AlmenoffKarol Lacroix

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Citations

Jul 24, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ola CasterG Niklas Norén
Mar 7, 2014·European Journal of Clinical Pharmacology·Francesco SalvoAntoine Pariente
Jun 15, 2012·Research in Social & Administrative Pharmacy : RSAP·Natasa GisevTimothy F Chen
Nov 24, 2016·Pharmacoepidemiology and Drug Safety·Alexandra C PacurariuSabine M Straus
Jun 28, 2017·Pharmacoepidemiology and Drug Safety·Ola CasterG Niklas Norén
Dec 1, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Mickael ArnaudFrancesco Salvo
Oct 17, 2018·Topics in Stroke Rehabilitation·Maribeth Anne P Gelisanga, Edward James R Gorgon
Jun 18, 2010·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Manfred Hauben, G Niklas Norén
May 26, 2018·Pharmacoepidemiology and Drug Safety·Widya N InsaniLiana Gross-Martirosyan
Jan 1, 2017·Therapeutic Innovation & Regulatory Science·Jeremy D JokinenMelissa Truffa
Apr 18, 2021·Cognitive, Affective & Behavioral Neuroscience·Xiaotong WenXia Wu

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