[R] R and FDA trials

Ricardo Pietrobon pietr007 at mc.duke.edu
Mon Oct 8 02:40:56 CEST 2007

Yesterday I just noticed the new document on R and regulatory aspects
for biomedical research posted at

Coming from an institution that performs a large number of clinical
trials for FDA and being an advocate of R myself, I have found that
the following issues usually come up when discussing the use of R for
FDA trials:

1. Most FDA submissions come down to a series of r x k tables, and it
is hard to claim that one system is better than another for that.

2. Data is to be submitted to the FDA in SAS (considered by many as
the industry standard) or CDISC XML formats (http://www.cdisc.org/);
there are pretty good SAS tools for that;  does R have comparable?

3. Some packages in R provide acknowledgedly better functionality than
their SAS-equivalent, but an entire FDA validation would have to occur
each time an enhancement is made to the R package because often an
enhancement breaks something else or the syntax would change from one
release to another.

would be interested in opinions on how to respond to these comments


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