Re: [R] "R is not a validated software package.."

From: Wensui Liu <>
Date: Fri, 08 Jun 2007 13:03:04 -0400

I just want to make sure what I said is not overstated to offend statistician who use SAS. actually, i am using SAS daily and able to use it pretty well. ^_^
What I meant are:
1) I don't understand the mentality
2) using SAS instead of R might be related to job-security. which is very different from "their mentality is related to job security".

On 6/8/07, Bert Gunter <> wrote:
> Frank et. al:
> I believe this is a bit too facile. 21 CFR Part 11 does necessitate a
> software validation **process** -- but this process does not require any
> particular software. Rather, it requires that those using whatever software
> demonstrate to the FDA's satisfaction that the software does what it's
> supposed to do appropriately. This includes a lot more than assuring, say,
> the numerical accuracy of computations; I think it also requires
> demonstration that the data are "secure," that it is properly transferred
> from one source to another, etc. I assume that the statistical validation of
> R would be relatively simple, as R already has an extensive test suite, and
> it would simply be a matter of providing that test suite info. A bit more
> might be required, but I don't think it's such a big deal.
> I think Wensui Liu's characterization of clinical statisticians as having a
> mentality "related to job security" is a canard. Although I work in
> nonclinical, my observation is that clinical statistics is complex and
> difficult, not only because of many challenging statistical issues, but also
> because of the labyrinthian complexities of the regulated and extremely
> costly environment in which they work. It is certainly a job that I could
> not do.
> That said, probably the greatest obstacle to change from SAS is neither
> obstinacy nor ignorance, but rather inertia: pharmaceutical companies have
> over the decades made a huge investment in SAS infrastructure to support the
> collection, organization, analysis, and submission of data for clinical
> trials. To convert this to anything else would be a herculean task involving
> huge expense, risk, and resources. R, S-Plus (and much else -- e.g. numerous
> "unvalidated" data mining software packages) are routinely used by clinical
> statisticians to better understand their data and for "exploratory" analyses
> that are used to supplement official analyses (e.g. for trying to justify
> collection of tissue samples or a pivotal study in a patient subpopulation).
> But it is difficult for me to see how one could make a business case to
> change clinical trial analysis software infrastructure from SAS to S-Plus,
> SPSS, or anything else.

> My opinions only. They do not in any way represent the view of my company or
> its employees.
> Bert Gunter
> Genentech Nonclinical Statistics
> South San Francisco, CA 94404
> 650-467-7374
> -----Original Message-----
> From:
> [] On Behalf Of Frank E Harrell Jr
> Sent: Friday, June 08, 2007 7:45 AM
> To: Giovanni Parrinello
> Cc:
> Subject: Re: [R] "R is not a validated software package.."
> Giovanni Parrinello wrote:
> > Dear All,

> > discussing with a statistician of a pharmaceutical company I received
> > this answer about the statistical package that I have planned to use:
> >
> > As R is not a validated software package, we would like to ask if it
> > would rather be possible for you to use SAS, SPSS or another approved
> > statistical software system.
> >
> > Could someone suggest me a 'polite' answer?
> > TIA
> > Giovanni
> >
> Search the archives and you'll find a LOT of responses.
> Briefly, in my view there are no requirements, just some pharma
> companies that think there are. FDA is required to accepted all
> submissions, and they get some where only Excel was used, or Minitab,
> and lots more. There is a session on this at the upcoming R
> International Users Meeting in Iowa in August. The session will include
> dicussions of federal regulation compliance for R, for those users who
> feel that such compliance is actually needed.
> Frank

> --
> Frank E Harrell Jr Professor and Chair School of Medicine
> Department of Biostatistics Vanderbilt University
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WenSui Liu
A lousy statistician who happens to know a little programming

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Received on Fri 08 Jun 2007 - 17:11:39 GMT

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