[Date Prev][Date Next][Thread Prev][Thread Next][Date index][Thread index]

Re: st: clinical trials

From   David Airey <[email protected]>
To   [email protected]
Subject   Re: st: clinical trials
Date   Fri, 4 Jan 2008 12:08:44 -0600


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.


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.


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

*   For searches and help try:

© Copyright 1996–2024 StataCorp LLC   |   Terms of use   |   Privacy   |   Contact us   |   What's new   |   Site index