[R] FDA and ICH Compliance of R

Antonia Drugica antoniamarija at net.hr
Fri Nov 28 08:37:37 CET 2003

Concerning the debate about SAS vs. S/R I think that a multiple approach
has to be taken. As far as I observed it many Pharmas are going to use more
than one Spftwarepackage. We all now that S SAS SPSS and so on have their
advantages and disatvantages. I think a modern statistician has to know at
least three or four softwarepackages so that he can decide which problem
can be solved by which software.

>On Thu, 27 Nov 2003 07:48:02 +0100
>"Antonia Drugica" <antoniamarija at net.hr> wrote:
>> I'm quite new to this medical stuff. But my associates told me that we
>> are not free in choice of Statistical Software because the FDA has high
>> standards concerning this topic. But if they would prefer a specific
>> package (like SAS) that could mean, that this package vendourer could
>> lay back and hold it's hand open for licence money.
>Your associates are completely wrong.  It is only sponsors that choose not
>to be free in their choice, due in my humble opinion mainly to the fact
>that SAS has been in use since 1966 and that "no one has ever been
>criticized by the FDA for using SAS."  FDA even receives submissions based
>on Excel and we all know about the accuracy of Excel's statistical
>calculations.  High standards need to be held by statisticians doing the
>analyses.  Related to such standards open source systems such as R have
>many advantages, and the reproducible reporting capabilities of R using
>its Sweave package have major impacts on accuracy of reporting.
>I along with colleagues at another institution are working on an open
>source R package for clinical trial analysis and reporting that should be
>mature in about a year.  I am currently using the package in two
>pharmaceutical industry-sponsored randomized clinical trials to report to
>data monitoring committees.  I'm also working on a document addressing
>validation of statistical calculations.  Let me know if you'd like a copy
>of the current version of that document.
>> Is there any part of the ICH document referring to software packages? I
>> really would use R for some tasks but therefor I need arguments...
>Don't know of anything in ICH.
>In view of the fact that large pharma companies have to pay more than $10M
>per year in SAS licenses and have to hire armies of non-intellectually
>challenged SAS programmers to do the work of significantly fewer
>programmers that use modern statistical computing tools like R and S-Plus,
>it is surprising that SAS is still the most commonly used tool in the
>clinical side of drug development.  I quit using SAS in 1991 because my
>productivity jumped at least 20% within one month of using S-Plus.
>Frank E Harrell Jr    Professor and Chair            School of Medicine
>                      Department of Biostatistics    Vanderbilt University

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