Working on a drug safety project

November 20, 2009

(This article was first published on Realizations in Biostatistics, and kindly contributed to R-bloggers)

In order to move some of my personal interests along, I have been trying to implement the methodology found in Berry and Berry’s article Accounting for Multiplicities in Assessing Drug Safety. This methodology uses the MedDRA hierarchy to improve the power of detecting damage to a particular organ. (The drawback, of course, is that MedDRA system organ classes do not perfectly correspond to the biology.) Apparently some other groups have already done so, but these implementations are hiding in paid software or on people’s local drives, but doing my own implementation in R is a good learning experience.

I’ve been working on this project for some time now, off an on. Well, I’ve been making progress, and I’ll share the results when I’m done. I’d also like to implement some of the other similar algorithms in this area, including the Poisson model that accounts for multiple occurrences of an adverse event, and a recent methodology that looks for “syndromes” (i.e. occurrences of groups of specific events all of which arise within a short time) and “constellations” (where the time restrictions are relaxed).

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