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

From: Sicotte, Hugues Ph.D. <Sicotte.Hugues_at_mayo.edu>
Date: Fri, 08 Jun 2007 09:40:59 -0500

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.

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.

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.

http://www.msmiami.com/custom/downloads/S-PLUSValidationdatasheet_Final. pdf

-----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 security.

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?
> 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: parrinel_at_med.unibs.it
>
>
> [[alternative HTML version deleted]]
>
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>

-- 
WenSui Liu
A lousy statistician who happens to know a little programming
(http://spaces.msn.com/statcompute/blog)

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Received on Fri 08 Jun 2007 - 15:29:08 GMT

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