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Re: RE: st: clinical trials

From   [email protected]
To   [email protected]
Subject   Re: RE: st: clinical trials
Date   Fri, 04 Jan 2008 11:49:14 -0600

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 this 
> 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.

Others posted their experiences and pointed out the -fdasave-

Peter (Tony) Lachenbruch <[email protected]>
indicates that the FDA allows Stata and other packages as part of
a submission to the FDA:

> 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.

For more information on FDA software requirements and how Stata
addresses those see:

As noted on that page, StataCorp validates Stata with over a half
million lines of test code (.do files) that produces over a
million lines of output.  A full validation run is made before
any update of Stata is sent to users.

As Tony notes Stata has been used for NDA submission to the FDA.
In fact that is why we added the -fdasave- and -fdause- commands
to Stata.

Should any questions arise about using Stata when submitting to
any government agency (including the FDA), StataCorp will assist
you in resolving them.

Ken Higbee    [email protected]
StataCorp     1-800-STATAPC

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