StATS: How do you analyze safety data (created 2008-01-22).
Someone on the MedStats email discussion group asked about how to analyze adverse event data. He noted that adverse event data is not one of the primary or secondary outcome measures, and wondered if it would be appropriate to provide statistical analysis of this data.
Adverse events (and safety data in general) represent a special type of analysis that does not fit in well with the listing of primary/secondary outcomes. The main reason for this is the number of possible adverse event categories is very broad and it is not always possible to anticipate in advance what type of adverse events are of greatest interest.
You have to analyze adverse events, of course. To ignore them is just bad research. But there is no clear consensus on how to analyze adverse event reports or safety data in general. Here are some of my random thoughts.
All of the above are just my opinions, of course, and I don't want to pretend that they are drawn from any consensus opinion among researchers.
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.