[R] "R is not a validated software package.."
Sicotte, Hugues Ph.D.
Sicotte.Hugues at mayo.edu
Fri Jun 8 18:37:32 CEST 2007
I may have overstated things a bit.
See section VIII
If you are analyzing data your statistical package does not necessarely
have to be validated. You may have to show that the statistical methods
are adequate/appropriate or that the results are reproduced with
different softwares if you are using non-standard packages. By all
tests, S-plus appears acceptable, do not know about R.
However, If your statistical method is an intricate part of a test, then
you do have to validate the system.
This is becoming increasingly relevant for theragnostics.
.. Which is why I said
"Should they need to use those results in a report [where] that will
matter to the FDA.."
(I added the where .. It makes more sense)
From: Frank E Harrell Jr [mailto:f.harrell at vanderbilt.edu]
Sent: Friday, June 08, 2007 11:08 AM
To: Sicotte, Hugues Ph.D.
Cc: Wensui Liu; Giovanni Parrinello; r-help at stat.math.ethz.ch
Subject: Re: [R] "R is not a validated software package.."
Sicotte, Hugues Ph.D. wrote:
> People, don't get angry at the pharma statistician, he is just trying
> abide by an FDA requirement that is designed to insure that test
> reliably the same. There is no point in getting into which product is
> better. As far as the FDA rules are concerned a validated system beats
> "better" system any day of the week.
There is no such requirement.
> Here is your polite answer.
> You can develop and try your software in R.
> Should they need to use those results in a report that will matter to
> the FDA, then you can work together with him to set up a validated
> environment for S-plus. You then have to commit to port your code to
That doesn't follow. What matters is good statistical analysis practice
no matter which environment you use. Note that more errors are made in
the data preparation / derived variables stage than are made by
> As I assume that you do not work in a regulated environment, you
> probably wouldn't have access to a validated SAS environment anyways.
> is not usually enough to install a piece of software, you have to
> validate every step of the installation. Since AFAIK the FDA uses
> S-plus, it would be to your pharma person's advantage to speed-up
> submissions if they also had a validated S-plus environment.
> -----Original Message-----
> From: r-help-bounces at stat.math.ethz.ch
> [mailto:r-help-bounces at stat.math.ethz.ch] On Behalf Of Wensui Liu
> Sent: Friday, June 08, 2007 9:24 AM
> To: Giovanni Parrinello
> Cc: r-help at stat.math.ethz.ch
> Subject: Re: [R] "R is not a validated software package.."
> I like to know the answer as well.
> To be honest, I really have hard time to understand the mentality of
> clinical trial guys and rather believe it is something related to job
> On 6/8/07, Giovanni Parrinello <parrinel at med.unibs.it> 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?
>> dr. Giovanni Parrinello
>> External Lecturer
>> Medical Statistics Unit
>> Department of Biomedical Sciences
>> Viale Europa, 11 - 25123 Brescia Italy
>> Tel: +390303717528
>> Fax: +390303717488
>> email: parrinel at med.unibs.it
>> [[alternative HTML version deleted]]
>> R-help at stat.math.ethz.ch mailing list
>> PLEASE do read the posting guide
>> and provide commented, minimal, self-contained, reproducible code.
Frank E Harrell Jr Professor and Chair School of Medicine
Department of Biostatistics Vanderbilt
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