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

[Frank E Harrell Jr]

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

For database software and for medical devices -

> 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.

What I would love to have is some efficiency estimates for SAS macro 
programming as done in pharma vs. using a high-level language.  My bias 
is that SAS macro programming, which costs companies more than SAS 
licenses, is incredibly inefficient.

Frank

> 
> **DISCLAINMER** 
> 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: r-help-bounces at stat.math.ethz.ch
> [mailto:r-help-bounces at stat.math.ethz.ch] On Behalf Of Frank E Harrell Jr
> Sent: Friday, June 08, 2007 7:45 AM
> To: Giovanni Parrinello
> Cc: r-help at stat.math.ethz.ch
> 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