sas vs. r

"wensui liu" <liuwensui at hotmail.com> writes:

I like R more than SAS. My job is doing research on clinical
trial. But I was told that FDA only accepts the result from SAS. Is
that true? TOO BAD.

No.  But it's not that simple.

See previous postings (within the last 2 months) on validation and
FDA. 

best,
-tony

A.J. Rossini  /  rossini at u.washington.edu  /  rossini at scharp.org
Biomedical/Health Informatics and Biostatistics, University of Washington.
Biostatistics, HVTN/SCHARP, Fred Hutchinson Cancer Research Center.
FHCRC: 206-667-7025 (fax=4812)|Voicemail is pretty sketchy/use Email 

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-----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 06, 2003 1:16 PM
To: r-help at stat.math.ethz.ch
Subject: [R] sas vs. r


I like R more than SAS. My job is doing research on clinical 
trial. But I was told that FDA only accepts the result from 
SAS. Is that true? TOO BAD.

See these recent posts by Frank Harrell:

http://maths.newcastle.edu.au/~rking/R/help/03a/4210.html

http://maths.newcastle.edu.au/~rking/R/help/03a/4231.html

http://maths.newcastle.edu.au/~rking/R/help/03a/4246.html


HTH,

Marc Schwartz

Please check "http://www.r-project.org/" -> search -> "R site 
search".  My search just now for "R vs. SAS for FDA" produced 14 matches.

	  My bottom line from reading comments on this issue is that it is like 
the comment 20 years ago that, "Nobody in management ever got fired for 
buying IBM."  The "r-help" archives include comments that FDA has no 
specific guidelines for what software must be used, although there are 
doubtless general guidelines relating to documentation and testing that 
it does what it claims.

hth.  spencer graves

I like R more than SAS. My job is doing research on clinical trial. But I was told that FDA only accepts the result from SAS. Is that true? TOO BAD.



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I like R more than SAS. My job is doing research on clinical trial. But
I was told that FDA only accepts the result from SAS. Is that true? TOO
BAD.

No, it isn't true.  The FDA does not approve or certify statistical
software. Its main regulation relevant to statistical analysis is in 21
CFR 11, and is largely about audit trails.  In fact the FDA is very
reluctant to issue blanket approval or disapproval for anything -- it
likes to keep its options open.


On the other hand, if a company has been successful in getting FDA
approval with analyses done one way, there is a substantial incentive not
to change. Why take the risk that it might slow down the approval of your
application?


	-thomas