StATS: Data mining and drug safety (created 2006-05-04).

I am very interested in safety issues, especially in the continuing review/interim analysis of clinical trials. It turns out that S-plus is targeting drug safety as a particularly important application of its data mining modules. Two recent web seminars addressed this topic:

There are not any public links to these presentations, but you should be able to register at the S-plus website ( and get access to them.

I want to use control charts to monitor safety data. I think it is a nice complement to the more complex data mining approaches advocated here (and by others as well). The control charts are a simple approach that pretty much anyone can use. It helps distinguish between signals and noise and has been optimized over years of work in business and industry. Data mining tools can look at more complex interrelationships among variables, and will be more effective in the hands of a trained statistician that a control chart would. Nevertheless, a control chart is still valuable because it will be used more often by non-statisticians and will allow more people to engage themselves in the examination of safety issues.

This page was written by Steve Simon while working at Children's Mercy Hospital. Although I do not hold the copyright for this material, I am reproducing it here as a service, as it is no longer available on the Children's Mercy Hospital website. Need more information? I have a page with general help resources. You can also browse for pages similar to this one at Category: Adverse events in clinical trials.