Drug Safety

, Volume 30, Issue 7, pp 611–613 | Cite as

Epidemiological Context of Signalling

Conference Paper


Epidemiology has become the conscience and soul of signal detection and interpretation from assuring insights into the strengths and limitations of the data source to articulating the disease natural history and its relationship to other diseases, outcomes and treatments. The epidemiologist has struggled to bring several issues into focus including the analysis and interpretation of surveillance data, the integration of signalling and causality criteria, the statistical issues of multiple comparisons and multiple looks at the data, whether one significant disproportion is a signal or whether it should persist over time before it is ‘declared’. However, epidemiology, like signalling, has its proper place with its own strengths and limitations. This paper will attempt to bring everyone up to speed on the role of epidemiology in the context of signalling and how signalling fits into the broader context of epidemiology, how perceptions and biases may affect our application of these methods and why context and communication have become so important in this field.


Surveillance Data Watchful Waiting Innocent Bystander Natural Remedy Causality Criterion 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.



No sources of funding were used to assist in the preparation of this paper. The author has no conflicts of interest that are directly relevant to the content of this paper.


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Copyright information

© Adis Data Information BV 2007

Authors and Affiliations

  1. 1.Johnson & Johnson Pharmaceutical Research and DevelopmentTitusvilleUSA

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