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RE: st: clinical trials

From   "Lachenbruch, Peter" <[email protected]>
To   <[email protected]>
Subject   RE: st: clinical trials
Date   Fri, 4 Jan 2008 08:48:07 -0800

I worked at FDA for 12 years and any statistical program was acceptable
for use.  The only requirement was that data sets had to be submitted in
SAS Transport version 5 format (XPORT).  We had some occasions in which
some clever programmer submitted the data in CPORT which was not
readable.  The idea was that since the data and report would be archived
it had to be retrievable in the future.  XPORT creates ASCII files and
FDA was comfortable about that.  The reports were in pdf files. 

At any rate, the bottom line is that any validated statistical program
can be used.  If the FDA requested proof of validation, they wanted to
see the PROCESS by which the programs were validated, not the validation
runs themselves.  For example, Stata has many (say S) scripts that
generate k*S  pages of output.  FDA wants the S scripts (probably only a
sample - talk with them if it's an issue).  

Other programs that have been used include SAS (obviously), R, SPlus,
SPSS (occasionally), StatXact.  

The bottom line is that you can talk to FDA about this.  If they insist
on SAS, they are out of line.


Peter A. Lachenbruch
Department of Public Health
Oregon State University
Corvallis, OR 97330
Phone: 541-737-3832
FAX: 541-737-4001

-----Original Message-----
From: [email protected]
[mailto:[email protected]] On Behalf Of Jeph Herrin
Sent: Thursday, January 03, 2008 6:52 PM
To: [email protected]
Subject: Re: st: clinical trials

I've published a few RCTs that I analyzed using Stata,
and have a few more in the hopper. These are, however,
in the area of Health Services Research, where the FDA
has no presence.

David Airey wrote:
> .
> Does anyone on the list use Stata for clinical trials analysis? I get 
> the impression companies that specialize in this field use SAS almost 
> exclusively. From what I know of Stata's feature set, I don't think
> is because Stata cannot be use to perform analysis of clinical trials 
> data. SAS certainly pushes this area of use with SAS, and they have 
> several SAS published how-to texts.
> -Dave
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