Re: st: clinical trials

[David Airey <david.airey@Vanderbilt.Edu>]

.

Basically all (corporate) job ads for this field require SAS  
expertise. But from your described experience, this has nothing to do  
with the FDA, and everything to do with successful SAS marketing and  
clinical trials CROs already being invested with a SAS code base.

I brought up the clinical trails question for a number of reasons, one  
being that I was surprised by the SAS dominance. I started using Stata  
at the 7/8 version change. There were some obvious features missing in  
Stata 7/8 compared to SAS at that time. These days, with Stata 10, it  
is me that is lagging Stata in features! The completeness of the Stata  
product juxtaposed against a lack of visibility in areas of  
"analytics" and "clinical trials" in the corporate sector caught my  
attention (I work in academia). Learning that U Chicago Med switched  
to Stata was eye opening, as was Dr. Lachenbruch's comments. I guess  
market dominance is hard to compete against. 5 years of great products  
and amazing visibility for Apple have only resulted in a few  
percentages gained in OS market share against Microsoft.

Thanks.


On Jan 4, 2008, at 10:48 AM, Lachenbruch, Peter wrote:


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