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

From: Frank E Harrell Jr <>
Date: Fri, 08 Jun 2007 11:08:19 -0500

Sicotte, Hugues Ph.D. wrote:
> People, don't get angry at the pharma statistician, he is just trying to
> abide by an FDA requirement that is designed to insure that test perform
> 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 a
> "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
> S-plus.

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 statistical software.


> As I assume that you do not work in a regulated environment, you
> probably wouldn't have access to a validated SAS environment anyways. It
> 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.
> pdf
> -----Original Message-----
> From:
> [] On Behalf Of Wensui Liu
> Sent: Friday, June 08, 2007 9:24 AM
> To: Giovanni Parrinello
> Cc:
> 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
> security.
> On 6/8/07, 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
>> --
>> dr. Giovanni Parrinello
>> External Lecturer
>> Medical Statistics Unit
>> Department of Biomedical Sciences
>> Viale Europa, 11 - 25123 Brescia Italy
>> Tel: +390303717528
>> Fax: +390303717488
>> email:
>>         [[alternative HTML version deleted]]
>> ______________________________________________
>> 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 University

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Received on Fri 08 Jun 2007 - 16:14:09 GMT

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