[R] Use of R in clinical trials
Peter Dalgaard
p.dalgaard at biostat.ku.dk
Thu Feb 18 20:15:55 CET 2010
Christopher W. Ryan wrote:
> Pure Food and Drug Act: 1906
> FDA: 1930s
> founding of SAS: early 1970s
>
> (from the history websites of SAS and FDA)
>
> What did pharmaceutical companies use for data analysis before there was
> SAS? And was there much angst over the change to SAS from whatever was
> in use before?
>
> Or was there not such emphasis on and need for thorough data analysis
> back then?
Well, I'm not quite old enough for this, but the story I heard is that
before SAS was the desktop calculator, essentially. Statistics had
correspondingly enormous focus on balanced designs, allowing computation
to be reduced to means and sums of squares. This would typically be left
to consulting firms employing (human) computers to literally do the
sums. Digital computers had of course been around for decades at the
time but mostly for hard core physics. (Well, actually, they were
finding their way into accounting too.) So SAS was, I expect, pretty
uniformly a relief.
At the same time, the requirements of the FDA have been tightening; I
suppose partly due to technological feasibility, partly in response to
certain practises being recognised as dubious, like selective
publication, multiple testing, etc. And more data are required since new
drugs are rarely all that much better than older ones, while the worries
about side effects have increased.
> --Chris
> Christopher W. Ryan, MD
> SUNY Upstate Medical University Clinical Campus at Binghamton
> 425 Robinson Street, Binghamton, NY 13904
> cryanatbinghamtondotedu
--
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c/ /'_ --- Dept. of Biostatistics PO Box 2099, 1014 Cph. K
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