[R] R and FDA trials

Frank E Harrell Jr f.harrell at vanderbilt.edu
Mon Oct 8 04:25:58 CEST 2007

Ricardo Pietrobon wrote:
> Yesterday I just noticed the new document on R and regulatory aspects
> for biomedical research posted at
> http://www.r-project.org/doc/R-FDA.pdf
> 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.

Your item 3. is up to the company's policy.  FDA does not require it and 
the word "validation" is not well defined in this context.  No package 
does a complete validation any time any piece of the package is enhanced.


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

Frank E Harrell Jr   Professor and Chair           School of Medicine
                      Department of Biostatistics   Vanderbilt University

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