[R] Use of R in clinical trials

[Bert Gunter]

Gentlemen:

Thankyou for your comments. I know I promised not to respond, but I just
wanted to clarify something that Dieter mentioned below, not defend my
remarks.

I understand "validate code" per 21 CFR part 11 complance to mean that for
**ANY** code that is written, be it in SAS, R, VB, or whatever, that one
must undertake a rigorous process to demonstrate that the code has been
appropriately tested and documented, and that QC, history, traceability, and
change control processes are in place, and so forth (as per the reg). My
further understanding is that statistical "correctness" of the code is
actually not (much of, anyway) an issue. What is important is that the
documentation enables the code to be reproduced and used by other parties
(e.g. reviewers) so that they can test "correctness" with whatever means
they deem appropriate. So, again, as I understand it, there is no such thing
as SAS, R, STATA, EXCEL or whatever code being a priori "validated" or not.
The process must be undertaken for any corpus of code written in any
language that is part of any FDA submission. 

So my point in my original remarks was only that to replace a body of
already validated code in **any** language with a different body of code --
even in the SAME languaage-- is a time-consuming and costly effort. 

I hope this clarifies my remarks. Again, I appreciate the comments and would
again appreciate even more others more knowledgeable in these issues
correcting my misunderstandings or errors and adding further insight.

Cheers to all,

Bert Gunter
Genentech Nonclinical Statistics

-----Original Message-----
From: r-help-bounces at r-project.org [mailto:r-help-bounces at r-project.org] On
Behalf Of John Sorkin
Sent: Friday, February 19, 2010 4:56 AM
To: Dieter Menne; r-help at r-project.org
Subject: Re: [R] Use of R in clinical trials

Bert,
There is a lesson here. Just as intolerance of any statistical analysis
program (or system) other than SAS should lead to our being drive crazy, so
to should intolerance of
any statistical analysis program (or system) other than R. 
John  

>>> Dieter Menne <dieter.menne at menne-biomed.de> 2/19/2010 3:46 AM >>>

Bert,

I like your comments. There is one issue, however, that drives me crazy
whenever I meet a customer asking "You are not using SAS? Too bad, we need
validated results."


Bert Gunter wrote:
> 
> ...
> Also to reiterate, it's not only
> statistical/reporting functionality but even more the integration into the
> existing clinical database systems that would have to be rewritten **and
> validated**. 
> 
> 

Implicitly: Even if you let your cat enter SAS code, the results are
correct, because they SAS is validated.

Dieter



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